Product Code: BSY
FDA class 1
21 CFR 868.6810
Catheters, Suction, Tracheobronchial
Anesthesiology
The Catheters, Suction, Tracheobronchial are flexible catheters inserted through the mouth, nose, or tracheostomy tube to remove secretions from the trachea and bronchi, maintaining airway patency. They are classified as FDA Class 1, the lowest risk category, subject to general controls only with no premarket submission required. The product code is BSY, regulated under 21 CFR 868.6810 in the Anesthesiology specialty.
510(k)s
116
FEI Numbers
257
Registration Numbers
257
Unique Applicants
79
Years Active
27
Basic Information
- Product Code
- BSY
- Device Class
- FDA class 1
- Regulation Number
- 868.6810
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 4
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 116 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K031997 | MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEM | Nov 25, 2003 | Substantially Equivalent | MALLINCKRODT DAR S.R.L. |
| K992902 | AMBU HAND POWER SUCTION PUMP | Oct 25, 1999 | Substantially Equivalent | AMBU, INC. |
| K982945 | DUAL PURPOSE CLOSED CATHETER | Sep 22, 1998 | Substantially Equivalent | SPIRIT MEDICAL SYSTEMS, INC. |
| K981910 | SUCTION CATHETER | Aug 24, 1998 | Substantially Equivalent | NI-MED, INC. |
| K972258 | HI-CARE CLOSED SUCTION SYSTEM | Dec 29, 1997 | Substantially Equivalent | MALLINCKRODT MEDICAL |
| K973199 | AMSINO SUCTION CATHETER | Sep 10, 1997 | Substantially Equivalent | AMSINO INTL., INC. |
| K961707 | TRACH-EZE CLOSED VENTILATION SUCTION SYSTEM | Mar 11, 1997 | Substantially Equivalent | SORENSON CRITICAL CARE |
| K964369 | TRACH CARE SET WITH MICROBAN | Feb 11, 1997 | Substantially Equivalent | BALLARD MEDICAL PRODUCTS |
| K960488 | NEO 2 LINE SUCTION SYSTEM | Apr 26, 1996 | Substantially Equivalent | ALCOVE MEDICAL, INC. |
| K955831 | ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM | Mar 28, 1996 | Substantially Equivalent | SHERWOOD MEDICAL CO. |
| K955645 | CATH-GUIDE | Mar 12, 1996 | Substantially Equivalent | HUDSON RESPIRATORY CARE, INC. |
| K952396 | REDI NURSE SYSTEM (RNS) STERILE 0.9% SODIUM CHLORIDE SOLUTION | Aug 15, 1995 | Substantially Equivalent | CONTOUR FABRICATORS OF FLORIDA, INC. |
| K952395 | REDI NURSE SYSTEM (RNS) STERILE WATER FOR IRRIGATION | Aug 15, 1995 | Substantially Equivalent | CONTOUR FABRICATORS OF FLORIDA, INC. |
| K953226 | PULM O2 SUCTION CATHETER TRAYS | Aug 08, 1995 | Substantially Equivalent | PREMIUM PLASTICS, INC. |
| K951506 | SUCTION CATHETER KIT, STERILE, SINGLE-USE | Jul 03, 1995 | Substantially Equivalent | TRINITY LABORATORIES, INC. |
| K945994 | DUAL PURPOSE CATHETER | Jun 21, 1995 | Substantially Equivalent | UNIVERSAL MEDICAL PRODUCTS, INC. |
| K951745 | CONNECTING TUBE | May 30, 1995 | Substantially Equivalent | VITAL SIGNS, INC. |
| K945950 | TRIGUARD(TM) SUCTION SYSTEM | Dec 27, 1994 | Substantially Equivalent | VITAL SIGNS, INC. |
| K944251 | KENDALL MODU-VAC CLOSED SUCTION SYSTEM | Sep 21, 1994 | Substantially Equivalent | KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH |
| K935600 | TRACHEAL SUCTION CATHETER | May 10, 1994 | Unknown | PURITAS HEALTH CARE, INC. |
| K935583 | SUCTION SET, TRACHAEL | Apr 11, 1994 | Unknown | PURITAS HEALTH CARE, INC. |
| K935553 | MULLY SUCTION STRAIGHT WITH FINGERTIP/WITH FUNNEL/WITH VACUTIP | Jan 14, 1994 | Substantially Equivalent | PURITAS HEALTH CARE, INC. |
| K934723 | ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM | Nov 30, 1993 | Substantially Equivalent | SHERWOOD MEDICAL CO. |
| K925556 | ARGYLE ASPIR-FLEX SUCTION CATHETER | Jul 30, 1993 | Unknown | SHERWOOD MEDICAL CO. |
| K921851 | 4 SURE TM SUCTION CATHETERS & KITS | Jul 07, 1993 | Unknown | BOSTON PACIFIC MEDICAL, INC. |
| K922843 | DYNAREX SUCTION CATHETERS & KITS | Jan 11, 1993 | Substantially Equivalent | DYNAREX CORP. |
| K922148 | ARGYLE AERO-JET SUCTION CATHETER | Dec 07, 1992 | Substantially Equivalent | SHERWOOD MEDICAL CO. |
| K923098 | STERILE MUCOUS SPECIMEN TRAP, DISPOSABLE | Sep 21, 1992 | Substantially Equivalent | TRINITY LABORATORIES, INC. |
| K903480 | HANN-VAC TM, DISPOSABLE,SUCTION CATHETER | Oct 01, 1991 | Substantially Equivalent | UN-I-MED, INC. |
| K912596 | MECONIUM ASPIRATION | Jul 30, 1991 | Substantially Equivalent | PACIFIC DEVICE, INC. |
| K910239 | NEBU-SOL METERED DOSE DISPENSER (TM) | May 22, 1991 | Substantially Equivalent | DEY LABORATORIES, INC. |
| K910909 | MUCAID | May 20, 1991 | Substantially Equivalent | VYGON CORP. |
| K910908 | MUCAID WITH SUCTION CATHETER AND EXTENSION TUBING | May 20, 1991 | Substantially Equivalent | VYGON CORP. |
| K903552 | ORAL-CATH SUCTION CATHETER | Jan 02, 1991 | Substantially Equivalent | CONCORD PROTEX |
| K903740 | TRACH-EZE | Dec 06, 1990 | Substantially Equivalent | SOREX MEDICAL |
| K902093 | RESU-GARD CATHETER SUCTION | Oct 23, 1990 | Substantially Equivalent | AMG MEDICAL EQUIPMENTS, INC. |
| K903669 | GENESIS INSUFFLATING CATHETER | Sep 12, 1990 | Substantially Equivalent | GENERAL MEDICAL CO. |
| K902687 | STERI-CATH-DL | Aug 29, 1990 | Substantially Equivalent | CONCORD/PORTEX |
| K902814 | SUCTION CATHETER, STERILE | Aug 17, 1990 | Substantially Equivalent | ORION LIFE SYSTEMS, INC. |
| K902297 | BUSSE BAC/SHIELD | Aug 17, 1990 | Substantially Equivalent | BUSSE HOSPITAL DISPOSABLES, INC. |
| K902383 | STERI-CATH(TM) | Jul 12, 1990 | Substantially Equivalent | CONCORD/PORTEX |
| K896887 | TRACHAEL SUCTION SET | Apr 23, 1990 | Substantially Equivalent | ORION LIFE SYSTEMS, INC. |
| K896730 | SUCTION CATHETER STRAIGHT/COUDE | Mar 30, 1990 | Substantially Equivalent | UNOPLAST A/S |
| K896797 | SUCTION CATHETER KIT | Feb 16, 1990 | Substantially Equivalent | WESTMARK, STERILE PACKING SYSTEMS, INC. (SPS) |
| K896560 | MUCOUS TRAP | Jan 22, 1990 | Substantially Equivalent | WESTMARK, STERILE PACKING SYSTEMS, INC. (SPS) |
| K896321 | NO. 34100 - 8 FR & NO. 34400 - 14 FR CLOSED TRACH. | Nov 13, 1989 | Substantially Equivalent | SUPERIOR HEALTHCARE GROUP, INC. |
| K894299 | REPRO-MED EMERGENCY AIRWAY VACUUM SYSTEM | Sep 22, 1989 | Substantially Equivalent | REPRO-MED SYSTEMS, INC. |
| K892529 | REPRO-MED NEONATE ASPIRATION SYSTEM | Jun 12, 1989 | Substantially Equivalent | REPRO-MED SYSTEMS, INC. |
| K893462 | NU-TRAP SUCTION CATHETER W/MUCUS TRAP | Jun 08, 1989 | Substantially Equivalent | ATHEUS CORP. |
| K893204 | MUC-X | Jun 01, 1989 | Substantially Equivalent | ISLAND MEDICAL |
| K892441 | KENDALL CURITY SUCTION CATHETERS | May 31, 1989 | Substantially Equivalent | THE KENDAL CO. |
| K892343 | SUCTION CONTROL VALVE | Apr 24, 1989 | Substantially Equivalent | CONCORD/PORTEX |
| K890425 | NEOTECH MUCUS TRAP W/CATHETER | Apr 19, 1989 | Substantially Equivalent | NEOTECH PRODUCTS, INC. |
| K884944 | TU SUCTIONTRAP | Feb 03, 1989 | Substantially Equivalent | TULAN CORP. C/O RICHARD HAMER ASSOC. |
| K885131 | KIT PAK SUCTION CATHETER KIT | Jan 09, 1989 | Substantially Equivalent | KIT PAK, INC. |
| K883384 | TS1000 SUCTION TIP | Nov 02, 1988 | Substantially Equivalent | M.D. ENGINEERING, INC. |
| K882017 | RESPIRONICS SUCTIONEASY | Jul 14, 1988 | Substantially Equivalent | RESPIRONICS, INC. |
| K881428 | OXY-CATH | Jun 10, 1988 | Substantially Equivalent | PULMONARY MEDICAL DEVICES, INC. |
| K875058 | STERILE MUCUS SPECIMEN TRAP, MODELS 406 & 407 | Feb 12, 1988 | Substantially Equivalent | BUSSE HOSPITAL DISPOSABLES, INC. |
| K873810 | SAFETY SHIELD SUCTION CATHETER | Dec 11, 1987 | Substantially Equivalent | BALLARD MEDICAL PRODUCTS |
| K873610 | PEDIATRIC BUBBLE TRAP CAT. NO. B-100 | Nov 05, 1987 | Substantially Equivalent | AMERICAN OMNI MEDICAL, INC. |
| K873732 | TRACH CARE START KIT | Oct 13, 1987 | Substantially Equivalent | BALLARD MEDICAL PRODUCTS |
| K872621 | TRACH CARE CATHETER | Sep 15, 1987 | Substantially Equivalent | BALLARD MEDICAL PRODUCTS |
| K872141 | CENTURION SPECIMEN TRAP W/CATHETER | Aug 26, 1987 | Substantially Equivalent | TRI-STATE HOSPITAL SUPPLY CORP. |
| K872917 | JINOTTI SUCTION/OXYGEN INSUFFLATION CATHETER | Aug 11, 1987 | Substantially Equivalent | AMERICAN PHARMASEAL DIV. AHSC |
| K872283 | ORAL SUCTION CATHETER | Aug 03, 1987 | Substantially Equivalent | BALLARD MEDICAL PRODUCTS |
| K871825 | MECONIUM SUCTION CATHETER | Jun 29, 1987 | Substantially Equivalent | CONCORD LABORATORIES, INC. |
| K871949 | MMG DELEE SUCTION CATHETER W/MUCOUS TRAP | Jun 15, 1987 | Substantially Equivalent | MEDICAL TECHNOLOGIES OF GEORGIA |
| K871407 | MECONIUM ASPIRATOR | Jun 15, 1987 | Substantially Equivalent | INTERTECH RESOURCES, INC. |
| K870962 | GESCO ASPIRATOR | May 22, 1987 | Substantially Equivalent | GESCO INTL., INC. |
| K864535 | TRACHEOBRONCHIAL SUCTION CATHETER, CAT. NO. 6110 | Jan 06, 1987 | Substantially Equivalent | CONCORD LABORATORIES, INC. |
| K864468 | TRACHEOBRONCHIAL SUCTION CATHETER | Jan 06, 1987 | Substantially Equivalent | SHERIDAN CATHETER CORP. |
| K861949 | SUCTION CATHETER KIT | Oct 22, 1986 | Substantially Equivalent | MEDI-CRAFT LTD. |
| K863497 | SUCTION CATHETER KIT | Oct 06, 1986 | Substantially Equivalent | WELMED SYSTEMS, INC. |
| K862181 | MECONIUM SUCTION TRAP | Aug 13, 1986 | Substantially Equivalent | MICHAEL REESE HOSPITAL AND MEDICAL CENTER |
| K862132 | HCI MECONIUM ASPIRATOR | Jun 19, 1986 | Substantially Equivalent | HOSPITAL CONCEPTS, INC. |
| K860802 | TRACHEOBRONCHIAL SUCTION CATHETER | Apr 02, 1986 | Substantially Equivalent | SHERIDAN CATHETER CORP. |
| K854320 | ACKRAD ORAL SUCTION TUBE | Jan 10, 1986 | Substantially Equivalent | ACKRAD LABORATORIES |
| K851473 | VYGON DELEE SUCTION CATHETER CODE NO 533 | Jul 15, 1985 | Substantially Equivalent | VYGON CORP. |
| K852080 | PENNINE SUCTION CATHETERS | Jun 03, 1985 | Substantially Equivalent | PENNINE MEDICAL LTD. |
| K852079 | PENNINE DERBY YANKAUER | Jun 03, 1985 | Substantially Equivalent | PENNINE MEDICAL LTD. |
| K850864 | TRACHEOBRONCHIAL SUCTION KITS W/CATHETERS ETO | May 02, 1985 | Substantially Equivalent | PACO RESEARCH CORP. |
| K850784 | BRONCHITRAC L | Mar 25, 1985 | Substantially Equivalent | ACKRAD LABORATORIES |
| K850105 | KM PRODUCTS ASPIRATING TUBING | Mar 21, 1985 | Substantially Equivalent | KM PRODUCTS |
| K842166 | INTERMED, INS STERILE WATER/SALINE | Feb 12, 1985 | Substantially Equivalent | INTERMED, INC. |
| K850032 | A FAMILY OF TRACHEOBRONCHIAL SUCTION CATHETER PROD | Feb 01, 1985 | Substantially Equivalent | PACO RESEARCH CORP. |
| K843797 | STERILE SALINE SOLUTION | Jan 18, 1985 | Substantially Equivalent | PACO PHARMACEUTICAL SERVICES, INC. |
| K843076 | SUCTION CATHETER KIT | Nov 20, 1984 | Substantially Equivalent | TRAVENOL LABORATORIES, S.A. |
| K842779 | ACT, SUCTION TIP | Oct 12, 1984 | Substantially Equivalent | EDWARD MANOUGIAN, M.D. |
| K841425 | JINOTTI OXYGEN/SUCTION CATHETER | Sep 13, 1984 | Substantially Equivalent | RESEARCH MEDICAL, INC. |
| K842205 | OXY-VAC | Jun 25, 1984 | Substantially Equivalent | MEDI-TECH, INC. |
| K842198 | AMER. PHARMASEAL NO TOUCH SATIN CATHET | Jun 25, 1984 | Substantially Equivalent | AMERICAN PHARMASEAL DIV. AHSC |
| K841480 | INFECTION CONTROL VALVE | Apr 25, 1984 | Substantially Equivalent | SUPERIOR PLASTIC PRODUCTS CORP. |
| K840664 | TRACHEOSTOMY CLEANING TRAY | Mar 12, 1984 | Substantially Equivalent | AMERICAN PHARMASEAL DIV. AHSC |
| K833375 | DUAL PURPOSE CATHETER | Feb 10, 1984 | Substantially Equivalent | JINOTTI ENT INC. MEDICAL |
| K833908 | IRRI-CATH | Feb 04, 1984 | Substantially Equivalent | PORTEX, INC. |
| K833633 | BRONCHITRAC DF DUAL RESP/CATHETER | Dec 08, 1983 | Substantially Equivalent | ACKRAD LABORATORIES |
| K830709 | ARGYLE SUCTION CATHETERS | Mar 29, 1983 | Substantially Equivalent | SHERWOOD MEDICAL CO. |
| K822724 | SUCTION TUBES | Oct 13, 1982 | Substantially Equivalent | EXCO, INC. |
| K822398 | ACKRAD BRONCHITRAC | Oct 04, 1982 | Substantially Equivalent | ACKRAD LABORATORIES |
| K820369 | SUCTION CATHETERS & KITS | Apr 16, 1982 | Substantially Equivalent | AMERICAN PHARMASEAL DIV. AHSC |
| K820109 | RADIATION STERILIZED SUCTION CATHETERS | Jan 29, 1982 | Substantially Equivalent | TRAVENOL LABORATORIES, S.A. |
| K813324 | BODAI SWIVEL Y | Dec 29, 1981 | Substantially Equivalent | SONTEK INDUSTRIES, INC. |
| K813163 | SUCTION CATHETER | Dec 29, 1981 | Substantially Equivalent | NORTHERN MEDICAL INDUSTRIES |
| K813209 | TRACHEOBRONCHIAL SUCTION CATHETER | Dec 09, 1981 | Substantially Equivalent | HYDROMER, INC. |
| K812747 | ARGYLE SUCTION CATHETERS | Oct 23, 1981 | Substantially Equivalent | SHERWOOD MEDICAL CO. |
| K811542 | MGN SUCTION CATHETER | Jun 18, 1981 | Substantially Equivalent | MGN MEDICAL MANUFACTURING, INC. |
| K811241 | BODAI SUCTION -SAFE 4 | May 27, 1981 | Substantially Equivalent | SONTEK INDUSTRIES, INC. |
| K810023 | HYDROPHILIC COATED CATHETER | Feb 06, 1981 | Substantially Equivalent | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
| K801814 | CATHETER SUCTION TRACHEOBRONCHIAL | Aug 14, 1980 | Substantially Equivalent | CONCORD LABORATORIES, INC. |
| K801551 | ARGYLE SAF-T-MARK SUCTION CATHETER | Jul 21, 1980 | Substantially Equivalent | SHERWOOD MEDICAL CO. |
| K800503 | SUCTION CATHETER | Mar 18, 1980 | Substantially Equivalent | MEDI-CRAFT LTD. |
| K791253 | CONPHAR SUCTION CATHETER-W/0 CONTROL | Jul 30, 1979 | Substantially Equivalent | CONPHAR, INC. |
| K790606 | CATHETERS, GREENLINE SUCTION | Apr 23, 1979 | Substantially Equivalent | SNYDER LABORATORIES, INC. |
| K760427 | CATHETER, DOVER SUCTION W/ GLOVE | Sep 09, 1976 | Substantially Equivalent | WILL ROSS CO. |
| K760371 | VENT-O2-CATH | Aug 13, 1976 | Substantially Equivalent | DRYDEN CORP. |
FEI Numbers
This FDA classification entry is associated with 257 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 257 registration numbers. Click on an entry to view related FDA registrations.