Product Code: BZA
FDA class 1
21 CFR 868.5810
Connector, Airway (Extension)
Anesthesiology
The Connector, Airway (Extension) is a device used to extend or join components of an anesthesia or ventilator breathing circuit, maintaining the integrity of the gas pathway between the patient's airway and the ventilator or gas source. It is classified as FDA Class 1, the lowest risk category, subject to general controls only with no premarket submission required. The product code is BZA, regulated under 21 CFR 868.5810 in the Anesthesiology specialty.
510(k)s
94
FEI Numbers
161
Registration Numbers
161
Unique Applicants
59
Years Active
32
Basic Information
- Product Code
- BZA
- Device Class
- FDA class 1
- Regulation Number
- 868.5810
- 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 94 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K083702 | TRACH-ASSIST | Mar 05, 2009 | Substantially Equivalent | MERGENET MEDICAL |
| K954383 | SURELOC CIRCUIT CONNECTOR | Dec 22, 1995 | Substantially Equivalent | POLAMEDCO, INC. |
| K954197 | DISPOSABLE FLEX TUBE | Oct 26, 1995 | Substantially Equivalent | ENGSTROM MEDICAL |
| K953786 | UNICOR, INC. CONNECTORS & AIRWAY EXTENSIONS | Sep 19, 1995 | Substantially Equivalent | UNICOR, INC. |
| K952824 | NEO-LINK, DISPOSABLE NEONATAL AIR WAY CONNECTOR | Jul 20, 1995 | Substantially Equivalent | INTERTEX MEDICAL, INC. |
| K951345 | DISPOSABLE AIRWAY CONNECTORS FOR GAS SAMPLING | Apr 14, 1995 | Substantially Equivalent | CATHETER RESEARCH, INC. |
| K944532 | PRIMA, INC. VENTILATOR HOSES | Dec 02, 1994 | Substantially Equivalent | PRIMA, INC. |
| K944535 | PRIMA, INC. GAS SAMPLING LINES AND CONNECTORS | Nov 29, 1994 | Substantially Equivalent | PRIMA, INC. |
| K944534 | PRIMA, INC. CONNECTORS AND AIRWAY EXTENSIONS | Nov 29, 1994 | Substantially Equivalent | PRIMA, INC. |
| K942392 | AIRWAY CONNECTOR WITH FLEX TUBE | Aug 22, 1994 | Substantially Equivalent | MALLINCKRODT MEDICAL |
| K941026 | THAYER MASK TO MOUTHPIECE ADAPTER/CONNECTOR | Aug 18, 1994 | Substantially Equivalent | THAYER MEDICAL CORP. |
| K940793 | DOUBLE TRACH SWIVEL CONNECTOR | Jul 01, 1994 | Substantially Equivalent | SEVEN HARVEST INTL. IMPORT & EXPORT |
| K940544 | DOUBLE TRACH SEIVEL CONNECTOR | Apr 19, 1994 | Substantially Equivalent | FVTNKS |
| K935821 | DOUBLE TRACH SWIVEL CONNECTOR | Jan 14, 1994 | Substantially Equivalent | NUTEC, INC. |
| K931800 | MAG CONNECTORS AND AIRWAY EXTENSIONS | May 19, 1993 | Substantially Equivalent | MAG, INC. |
| K931345 | CONNECTORS AND AIRWAY EXTENSIONS | Apr 23, 1993 | Substantially Equivalent | PRECISION MED PRODUCTS, LTD. |
| K931216 | CONNECTORS AND AIRWAY EXTENSIONS | Apr 23, 1993 | Substantially Equivalent | TEKNOR MEDICAL PRODUCTS, INC. |
| K931038 | CONNECTORS AND AIRWAY EXTENSIONS | Apr 08, 1993 | Substantially Equivalent | MED-PLASTICS INTL., INC. |
| K931036 | CONNECTORS AND AIRWAY EXTENSIONS | Apr 08, 1993 | Substantially Equivalent | LIFE SHIELD HEALTHCARE PRODUCTS, INC. |
| K925263 | MERIDIAN MEDICAL SYSTEMS CONNECTORS & AIRWAY EXT | Feb 02, 1993 | Substantially Equivalent | MERIT MEDICAL SYSTEMS, INC. |
| K922537 | DURALIFE | Dec 04, 1992 | Substantially Equivalent | DHD DIEMOLDING HEALTHCARE DIV. |
| K924225 | OXYGEN SWIVEL ADAPTER (PLASTIC) | Sep 04, 1992 | Substantially Equivalent | LINJOREL PRODUCTS, INC. |
| K921512 | ENTENDED LINE ACCESSORIES & CONNECTORS | Jun 17, 1992 | Substantially Equivalent | INTERSURGICAL, INC. |
| K921511 | CATHETER MOUNTS -- MODIFICATION | Jun 17, 1992 | Substantially Equivalent | INTERSURGICAL, INC. |
| K913726 | DURALIFE(TM) | Feb 07, 1992 | Substantially Equivalent | DHD DIEMOLDING HEALTHCARE DIV. |
| K913216 | TRACH T ADAPTER | Jan 15, 1992 | Substantially Equivalent | SPECIALTY PACKAGING PRODUCS, INC. |
| K912652 | FLEX-ELBOW | Oct 10, 1991 | Substantially Equivalent | VITAL SIGNS, INC. |
| K911425 | ACCESSORIES & CONNECTORS, 22MM-15MM-8.5MM | Jun 24, 1991 | Substantially Equivalent | INTERSURGICAL, INC. |
| K911421 | CATHETER MOUNTS | Jun 24, 1991 | Substantially Equivalent | INTERSURGICAL, INC. |
| K911294 | ULTRASET CATHETER | Jun 10, 1991 | Substantially Equivalent | DHD DIEMOLDING HEALTHCARE DIV. |
| K895549 | M.D.I. ADAPTER | Nov 21, 1989 | Substantially Equivalent | CUSTOM CONNECTION CORP. |
| K895014 | BAXTER BAFFLED TEE ADAPTER | Oct 30, 1989 | Substantially Equivalent | BAXTER HEALTHCARE CORP. |
| K894969 | AEROVENT | Oct 30, 1989 | Substantially Equivalent | MONAGHAN MEDICAL CORP. |
| K895388 | SHILEY ELBOW 15MM SWIVEL CONNECTOR | Oct 27, 1989 | Substantially Equivalent | SHILEY, INC. |
| K895144 | INTERTECH METERED DOSE ELBOW | Oct 19, 1989 | Substantially Equivalent | INTERTECH/OHIO |
| K884374 | E.T. PUFFER | Nov 23, 1988 | Substantially Equivalent | KALAJIAN ENT. |
| K881849 | BODAI M.D.D. ADAPTOR(TM) | Jul 01, 1988 | Substantially Equivalent | B & B MEDICAL TECHNOLOGIES, INC. |
| K882203 | NEOTECH UNIVERSAL ADAPTER | Jun 17, 1988 | Substantially Equivalent | NEOTECH PRODUCTS, INC. |
| K881230 | FLEX TUBE | Apr 14, 1988 | Substantially Equivalent | INTERTECH RESOURCES, INC. |
| K873696 | BODAI NEO2-SAFE(TM) | Apr 14, 1988 | Substantially Equivalent | B & B MEDICAL TECHNOLOGIES, INC. |
| K880434 | MEDICOMP STRAIGHT SWIVEL ADAPTOR | Mar 31, 1988 | Substantially Equivalent | MEDICOMP, INC. |
| K873974 | TILSON TRACH GUARD | Dec 22, 1987 | Substantially Equivalent | BEEVERS MFG. & SUPPLY, INC. |
| K871737 | CK 7000 SERIES 5 IN 1 CONNECTOR AND Y-CONNECTOR | Jun 22, 1987 | Substantially Equivalent | CURRIE MEDICAL SPECIALTIES, INC. |
| K864896 | MEDICOMP INHALANT MASK ELBOW | Feb 20, 1987 | Substantially Equivalent | MEDICOMP, INC. |
| K865046 | SALTER LABS MODEL #4005 GAS SAMPLING TEE AND LINE | Jan 15, 1987 | Substantially Equivalent | SALTER LABS |
| K862435 | DOUBLE LUMEN E T ADAPTOR | Oct 22, 1986 | Substantially Equivalent | ACUTRONIC MEDICAL SYSTEMS AG |
| K863318 | AEROSOL-T | Sep 11, 1986 | Substantially Equivalent | SOUTHMEDIC, INC. |
| K862433 | UNI-JET CONNECTOR | Aug 06, 1986 | Substantially Equivalent | ACUTRONIC MEDICAL SYSTEMS AG |
| K860838 | INSPIRON DOUBLE SWIVEL TRACH ADAPTER | Apr 09, 1986 | Substantially Equivalent | INSPIRON CORP. |
| K860650 | 90 DEGREE ELBOW & STRAIGHT CONNECTOR | Mar 28, 1986 | Substantially Equivalent | INTERTECH/OHIO |
| K861056 | STRAIGHT ADAPT W/TEMP SENSING PORT/CLOSURE PLUG | Mar 27, 1986 | Substantially Equivalent | INTERTECH/OHIO |
| K860885 | STRAIGHT CONNECTORS, 15MM, 30MM & 19MM | Mar 20, 1986 | Substantially Equivalent | DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP. |
| K860882 | DISPOSABLE CATHETER | Mar 20, 1986 | Substantially Equivalent | DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP. |
| K860878 | BRITISH BREATHING CIRCUIT SYSTEM | Mar 20, 1986 | Substantially Equivalent | DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP. |
| K860888 | CONNECTORS/VALVE INSERT | Mar 19, 1986 | Substantially Equivalent | DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP. |
| K860887 | T-PIECES CONNECTORS | Mar 19, 1986 | Substantially Equivalent | DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP. |
| K860886 | STRAIGHT CONNECTORS, 22MM | Mar 19, 1986 | Substantially Equivalent | DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP. |
| K860881 | CATHETER MOUNTS & ELBOWS (VARIOUS TYPES) | Mar 19, 1986 | Substantially Equivalent | DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP. |
| K860352 | SPACELABS AIRWAY ADAPTER SET SERIES, NO. 369014 | Mar 19, 1986 | Substantially Equivalent | SPACELABS, INC. |
| K853828 | FLS MED. PROD. RACINE TYPE ADAPTOR | Oct 29, 1985 | Substantially Equivalent | FLS MEDICAL PRODUCTS, INC. |
| K850964 | DOUBLE-SWIVEL CONNECTOR | May 14, 1985 | Substantially Equivalent | SHERIDAN CATHETER CORP. |
| K850625 | ARGYLE 15MM SWIVEL CONNECTOR | Mar 21, 1985 | Substantially Equivalent | SHERWOOD MEDICAL CO. |
| K844656 | OHMEDA DOUBLE SWIVEL ADAPTER | Feb 12, 1985 | Substantially Equivalent | OHMEDA MEDICAL |
| K840015 | SWIVEL ADAPTOR W/ALARM PORT | Jan 17, 1984 | Substantially Equivalent | PORTEX, INC. |
| K833373 | BODIA BRONCH-SAF DOUBLE SWIVEL | Nov 03, 1983 | Substantially Equivalent | SONTEK INDUSTRIES, INC. |
| K833372 | BODIA TRACH-SAF DOUBLE SWIVEL | Nov 03, 1983 | Substantially Equivalent | SONTEK INDUSTRIES, INC. |
| K813383 | DISPOSABLE TRACH SWIVEL CONNECTOR | Dec 31, 1981 | Substantially Equivalent | INTEC. |
| K812977 | RESPIRATORY CARE MONITOR | Nov 16, 1981 | Substantially Equivalent | ADVANCED MEDICAL EQUIPMENT, INC. |
| K812067 | INSPIRATORY FORCE PRESSURE ADAPTOR | Aug 12, 1981 | Substantially Equivalent | AIRLIFE, INC. |
| K812000 | PEDIATRIC DOUBLE SWIVEL CONNECTOR | Aug 03, 1981 | Substantially Equivalent | MALLINCKRODT CRITICAL CARE |
| K811922 | 45DEGREES SWIVEL ELBOW | Jul 23, 1981 | Substantially Equivalent | DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP. |
| K811890 | DISPOSABLE TRACH T OXYGENATOR | Jul 15, 1981 | Substantially Equivalent | AIRLIFE, INC. |
| K811708 | UNIVERSAL ADAPTER SYSTEM-U/ADAPIT | Jul 01, 1981 | Substantially Equivalent | AIRLIFE, INC. |
| K810621 | DISPOSABLE 22MM. FLEXIBLE ADAPTOR | Apr 17, 1981 | Substantially Equivalent | INTEC MEDICAL, INC. |
| K810620 | DISPOSABLE ELBOW ADAPTOR | Mar 20, 1981 | Substantially Equivalent | INTEC MEDICAL, INC. |
| K810361 | CONNECTOR ADAPTERS | Mar 17, 1981 | Substantially Equivalent | TODD INDUSTRIES, INC. |
| K802663 | BLOW-BY-SET-UP CONNECTOR-AIRWAY | Nov 12, 1980 | Substantially Equivalent | AIRLIFE, INC. |
| K791539 | DISPOSABLE 22MM ADAPTOR | Sep 07, 1979 | Substantially Equivalent | HOSPITAK, INC. |
| K791538 | DISPOSABLE AEROSOL T | Sep 07, 1979 | Substantially Equivalent | HOSPITAK, INC. |
| K791532 | SURELOC EXTERNAL CONNECTOR | Sep 04, 1979 | Substantially Equivalent | POLAMEDCO, INC. |
| K790888 | TRACH T WITH ONE-WAY VALVES | Jun 27, 1979 | Substantially Equivalent | AIRLIFE, INC. |
| K790887 | TEE ADAPTER | Jun 05, 1979 | Substantially Equivalent | AIRLIFE, INC. |
| K790156 | TRACH T W/DRAINAGE BAG | Apr 20, 1979 | Substantially Equivalent | AIRLIFE, INC. |
| K790157 | TRACH T ADAPTER | Feb 01, 1979 | Substantially Equivalent | AIRLIFE, INC. |
| K790155 | VENTILATOR ELBOW W/SUCTION PORT | Feb 01, 1979 | Substantially Equivalent | AIRLIFE, INC. |
| K790149 | MASK INTULATION ADAPTOR | Feb 01, 1979 | Substantially Equivalent | AIRLIFE, INC. |
| K790148 | CUFF CONNECTOR | Feb 01, 1979 | Substantially Equivalent | AIRLIFE, INC. |
| K781759 | RESCAL | Nov 27, 1978 | Substantially Equivalent | DIEMOLDING CORP. |
| K781395 | DISPOSABLE AEROSOL T BRIGGS ADAPTOR | Aug 31, 1978 | Substantially Equivalent | INHAL-O-TECH MEDICAL PLASTIC |
| K770630 | ADAPTER, UNIVERSAL, BE 105-6 | May 23, 1977 | Substantially Equivalent | INSTRUMENTATION INDUSTRIES, INC. |
| K770634 | ADAPTER BE 105-101 & 125-101 | Apr 08, 1977 | Substantially Equivalent | INSTRUMENTATION INDUSTRIES, INC. |
| K770587 | VENTILATOR ADAPTOR, #751 | Apr 05, 1977 | Substantially Equivalent | SURGICOT, INC. |
| K770585 | AEROSOL T ADAPTER, #752 | Apr 05, 1977 | Substantially Equivalent | SURGICOT, INC. |
| K770052 | VITAL-LOK TRACHEAL SWIVEL COUPLING | Jan 14, 1977 | Substantially Equivalent | V.F.P. CORP. |
FEI Numbers
This FDA classification entry is associated with 161 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 161 registration numbers. Click on an entry to view related FDA registrations.