Product Code: JOL FDA class 2 21 CFR 880.6740

Catheter And Tip, Suction

General Hospital

The Catheter and Tip, Suction is a general hospital device consisting of a catheter and its tip used to aspirate secretions, fluids, or debris from the airway, wound, or body cavities to maintain patency and cleanliness during clinical care. This device is FDA Class 2, indicating moderate risk, subject to general and special controls; however, it does not require a 510(k) for all configurations under its current submission type. It carries product code JOL and is regulated under 21 CFR 880.6740, within the General Hospital medical specialty.

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510(k)s

FEI Numbers

331

Registration Numbers

331

Unique Applicants

Years Active

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Basic Information

Product Code: JOL
Device Class: FDA class 2
Regulation Number: 880.6740
Medical Specialty: General Hospital
Review Panel: HO
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 84 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K051370	STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F8014	Aug 12, 2005	Substantially Equivalent	Baxter Healthcare Corp
K000266	PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION	Jul 12, 2001	Substantially Equivalent	Primary Care Solutions, Inc.
K000265	PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION	Jul 12, 2001	Substantially Equivalent	Primary Care Solutions, Inc.
K003402	WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATION	May 01, 2001	Substantially Equivalent	Welcon, Inc.
K994321	STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP	Oct 25, 2000	Substantially Equivalent	Automatic Liquid Packaging, Inc.
K974759	HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML 100 ML BOTTLE	Mar 09, 1998	Substantially Equivalent	Hydrox Laboratories
K974758	HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 100 ML BOTTLE	Mar 09, 1998	Substantially Equivalent	Hydrox Laboratories
K974397	STERILE SALINE FOR CATHETER CARE	Feb 10, 1998	Substantially Equivalent	Baxter Healthcare Corp
K973734	STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATION	Feb 05, 1998	Substantially Equivalent	Welcon, Inc.
K972372	GERM TRAPPER SUCTION TUBE HOLDER	Dec 11, 1997	Substantially Equivalent	Rzv Medical Specialties, Inc.
K960216	CPR SUCTION CATHETER KIT	Apr 15, 1996	Substantially Equivalent	Custom Pack Reliability
K954442	STERILE ISOTONIC SALINE & STERILE WATER	Dec 21, 1995	Substantially Equivalent	Medcare Custom Packaging, Inc.
K950201	ARGYLE(R) HYDROPHILIC COATED THORACIC CATHETER	Dec 15, 1995	Substantially Equivalent	Sherwood Medical Co.
K951524	THORACENTESIS CATHETER	Jul 06, 1995	Substantially Equivalent	Baxter Healthcare Corp
K945728	CATCO THORACIC CATHETER	May 23, 1995	Substantially Equivalent	Catco Medical, Inc.
K943661	STERILE PHYSIOLOGICAL SALINE/STERILE WATER	Apr 10, 1995	Substantially Equivalent	Medcare Custom Packaging, Inc.
K943773	STERILE WATER	Feb 27, 1995	Substantially Equivalent	Medline Industries, Inc.
K943836	PRE-FILLED 10CC INFLATION SYRINGE W/STERILE WATER	Nov 21, 1994	Substantially Equivalent	Orion Life Systems, Inc.
K943834	STERILE .9% SODIUM CHLORIDE SOLUTION	Nov 21, 1994	Substantially Equivalent	Orion Life Systems, Inc.
K943832	STERILE .9% SODIUM CHLORIDE FOR IRRATION	Nov 21, 1994	Substantially Equivalent	Orion Life Systems, Inc.
K943831	PRE-FILLED 30CC INFLATION SYRINGE W/STERILE WATER	Nov 21, 1994	Substantially Equivalent	Orion Life Systems, Inc.
K943830	PRE-FILLED SYRINGE W/STERILE 0.9% SODIUM CHLORIDE SOLUTION	Nov 21, 1994	Substantially Equivalent	Orion Life Systems, Inc.
K943829	PRE-FILLED SYSRINGE W/STERILE WATER	Nov 21, 1994	Substantially Equivalent	Orion Life Systems, Inc.
K943828	STERILE WATER FOR IRRIGATION	Nov 21, 1994	Substantially Equivalent	Orion Life Systems, Inc.
K932138	SALINE FOR IRRIGATION	Nov 04, 1994	Substantially Equivalent	Rantran, Inc.
K943833	STERILE WATER FOR IRRATION	Nov 01, 1994	Substantially Equivalent	Orion Life Systems, Inc.
K931509	GERITREX STERILE SALINE SOLUTION FOR IRRIGATION	Sep 22, 1994	Substantially Equivalent	Geritrex Corp.
K933762	STB YANKAUER SUCKER/NOZZLE	Jul 19, 1994	Substantially Equivalent	Save-T-Breath Distributors C.C.
K942061	DISPOSABLE SUCTION PROBE	May 16, 1994	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K941232	THORA-CATH	May 11, 1994	Substantially Equivalent	Gesco Intl., Inc.
K933526	STERILE WATER	Mar 10, 1994	Substantially Equivalent	Trinity Laboratories, Inc.
K931511	GERITREX STERILE WATER FOR IRRIGATION	Feb 14, 1994	Substantially Equivalent	Geritrex Corp.
K934382	VCI SUCTION/IRRIGATION TUBING SET	Feb 01, 1994	Substantially Equivalent	Vital Concepts, Inc.
K932185	SURGICAL SUCTION TIP	Oct 27, 1993	Substantially Equivalent	Tlc Medservices, Inc.
K922714	UNIVERSAL IRRIGATION & SUCTION TUBING SET	Aug 03, 1993	Substantially Equivalent	Ximed Medical Systems
K913896	JAIN BLOOD SHIELD	Mar 06, 1992	Substantially Equivalent	Jain Surgical Equipment, Inc.
K913876	ENDOTRACHEAL SUCTIONTUBE	Mar 06, 1992	Substantially Equivalent	Willowtech
K910693	PHARMASEAL THORACENTESIS TRAY W/UNIV DRAINAGE SET	Oct 17, 1991	Substantially Equivalent	Baxter Healthcare Corp
K910963	THOROCENTESIS KIT	Jun 20, 1991	Unknown	Megadyne Medical Products, Inc.
K904216	STERILE WATER SOLUTION CATALOG # 10000	Nov 16, 1990	Substantially Equivalent	Superior Healthcare Group, Inc.
K903569	CURITY THORACENTESIS TRAY	Sep 07, 1990	Unknown	Kendall Healthcare Products Co. Div.Of Tyco Health
K890039	KLEEN TEST BASIN SET	Oct 24, 1989	Substantially Equivalent	Kleen Test Products
K893667	SUCTION TIP	Aug 21, 1989	Substantially Equivalent	Thomson & Shelton Instrumentation Co, Inc.
K893527	LAPAROSCOPIC SUCTION PROBE	Jul 14, 1989	Substantially Equivalent	Dexide, Inc.
K893135	GENT-L-KARE STER SUCT CATH TRAY W/14 FR/STER WATER	Jun 22, 1989	Substantially Equivalent	Premium Plastics, Inc.
K883905	ARROW PNEUMOTHORAX KIT, AK-01500	Jan 19, 1989	Unknown	Arrow Intl., Inc.
K872948	URESIL THORA-FLO THORACENTESIS PROCEDURE KIT	Nov 27, 1987	Unknown	Uresil Corp.
K873563	APLICARE STERILE WATER - FOR SUCTION CATHETER ONLY	Nov 23, 1987	Substantially Equivalent	Aplicare, Inc.
K873464	VAN DELLEN CANNULA	Nov 23, 1987	Substantially Equivalent	Van Dellen, Ltd.
K873525	DEKNATEL TROCAR CATHETER	Nov 02, 1987	Substantially Equivalent	Deknatel, Inc.
K873517	DEKNATEL THORACIC CATHETER	Nov 02, 1987	Substantially Equivalent	Deknatel, Inc.
K871950	VIA-GUARD	Jul 23, 1987	Substantially Equivalent	Surgimark, Inc.
K870572	ARROW-CLARKE(TM) PLEURA-SEAL(TM) THORACENTESIS KIT	May 26, 1987	Substantially Equivalent	Arrow Intl., Inc.
K864937	'EXMOOR' ZOELLNER SUCKER ENDS	Mar 30, 1987	Substantially Equivalent	Exmoor Plastics , Ltd.
K860927	HD CRYSTALINE SUCTION TIP	Mar 27, 1986	Substantially Equivalent	Hospital Disposables, Inc.
K852041	DEKNATEL THORACIC CATHETER	Jun 17, 1985	Substantially Equivalent	Pfizer, Inc.
K851979	TROCAR CATHETER	Jun 17, 1985	Substantially Equivalent	Hospital Products Group
K851611	IMPACT TURBO CATH	Jun 05, 1985	Substantially Equivalent	Impact Instrumentation, Inc.
K851385	THORA-CATH TROCAR-TYPE CHEST DRAINAGE TUBE	May 23, 1985	Substantially Equivalent	Gesco Intl., Inc.
K850240	KM PRODUCTS SUCTION TIPS	Mar 06, 1985	Substantially Equivalent	Km Products
K843469	PHARMA-PLAST SUCTION TIP, TYPE ORTHOPAE-	Nov 19, 1984	Substantially Equivalent	Zimmar Consulting , Ltd.
K843188	WELLS JOHNSON CO. CHAJ-CHIR-SUCTION TIP	Sep 20, 1984	Substantially Equivalent	Wells Johnson Co.
K840669	SUCTION DEVICE-PHARYNEAL DEVICE	Jun 11, 1984	Substantially Equivalent	Lipsky-Dale Medical Products
K840007	SURGICAL SUCTION INSTRUMENT-REUSABLE	Mar 06, 1984	Substantially Equivalent	Lawton Surgical Instruments
K832880	TRACHEOSTOMY CARE TRAYS	Oct 31, 1983	Substantially Equivalent	Packaging Technologies, Inc.
K832517	CUSTOM KWIK SET AND/OR PAK	Oct 14, 1983	Substantially Equivalent	Norton Texas Medical Products
K831999	FEMORAL CANAL SUCTION TAMPON	Sep 29, 1983	Substantially Equivalent	Richards Manufacturer Co.
K832027	ARGYLE YANKAVER SUCTION TUBE W/CONTROL	Aug 08, 1983	Substantially Equivalent	Sherwood Medical Co.
K830942	SUCTION CATHETERS	Apr 14, 1983	Substantially Equivalent	Medovations, Inc.
K821342	METAL BACKED ACETABULAR COMPONENT	May 21, 1982	Substantially Equivalent	Intermedics Orthopedics
K820718	ARGYLE THORACIC CATHETERS	Apr 14, 1982	Substantially Equivalent	Sherwood Medical Co.
K820460	3.5 & 5.5 OZ. SODIUM CHLORIDE SOLUTION	Mar 08, 1982	Substantially Equivalent	Superior Plastic Products Corp.
K812312	STERILE WATER 4OZ.	Nov 13, 1981	Substantially Equivalent	Superior Plastic Products Corp.
K803206	SUCTION PROBE	Jan 21, 1981	Substantially Equivalent	Bemis Health Care
K803187	ARGYLE UNIVERSAL POOLE SUCTION TUBE	Jan 09, 1981	Substantially Equivalent	Sherwood Medical Co.
K801134	MICROVAC	May 30, 1980	Substantially Equivalent	Progress Mankind Technology
K801127	MACROVAC	May 30, 1980	Substantially Equivalent	Progress Mankind Technology
K800635	C.C.-PAK	Apr 10, 1980	Substantially Equivalent	Respiratory Care, Inc.
K800234	ABCO SUCTION CATHETER & KITS W/GLOVE&CUP	Feb 26, 1980	Substantially Equivalent	Abco Dealers, Inc.
K791801	CONPHAR FINGERTIP SUCTION CONTROL	Sep 21, 1979	Substantially Equivalent	Conphar, Inc.
K782027	HYSTERECTOMY T DRAIN	Dec 20, 1978	Substantially Equivalent	Davol, Inc.
K770983	CATHETER THORACIC, AXIOM	Jul 29, 1977	Substantially Equivalent	Axiom Medical, Inc.
K770233	STERILE SUCTION CATHETER W/CONTROL	Apr 05, 1977	Substantially Equivalent	Chesire Laboratories
K760586	SUCTION KIT	Nov 12, 1976	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic