Product Code: FPK FDA class 2 21 CFR 880.5440

Tubing, Fluid Delivery

General Hospital

The Fluid Delivery Tubing is a length of flexible tubing used within IV administration sets or medical fluid circuits to convey liquids from a source container to the patient or to a connecting device. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification. The product code is FPK, regulated under 21 CFR 880.5440 in the General Hospital specialty. This device is eligible for third-party review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: FPK
Device Class: FDA class 2
Regulation Number: 880.5440
Medical Specialty: General Hospital
Review Panel: HO
Submission Type: 1

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 64 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K131517	MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING	Aug 02, 2013	Substantially Equivalent	Medrad, Inc. / Bayer Medical Care, Inc.
K063114	DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES	Feb 09, 2007	Substantially Equivalent	Coeur, Inc.
K063239	LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528, 17527, 17525 & 17526	Dec 11, 2006	Substantially Equivalent	Hospira, Inc.
K052431	MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801S2, MMT-801L2, MMT-803S1	Nov 29, 2005	Substantially Equivalent	Medtronic Minimed
K041178	EMPOWER TRANSFER SET, (CAT. NO. 7725)	Jul 16, 2004	Substantially Equivalent	E-Z-Em, Inc.
K031808	MEDRAD SWABBABLE VALVE TRANSFER SET	Jul 11, 2003	Substantially Equivalent	Medrad, Inc.
K022431	MEDRAD TRANSFER SET	Sep 05, 2002	Substantially Equivalent	Medrad, Inc.
K965208	POLYFIN EXTENSION SET, MODELS 126 AND 128	Feb 26, 1997	Substantially Equivalent	Medtronic Minimed
K953864	SILCLEAR TUBING (MODIFICATION)	Nov 06, 1995	Substantially Equivalent	Degania Silicone , Ltd.
K950508	SYSMEX SF-3000	Nov 03, 1995	Substantially Equivalent	Sysmex Corp.
K952243	EXTENSION SET/I.V. SET	Jul 26, 1995	Substantially Equivalent	Coast Medical, Inc.
K952663	60 MICRO VOLUME EXTENSION SET W/.22 MICRON FILTER, 21 EXTENSION SET W/1.2 MIVTON GILYRT, INJ. SITE, CLAMP	Jul 14, 1995	Substantially Equivalent	Distronic Sterile Products, Inc.
K950861	RECONSTITUTION ACCESSOREIS	May 26, 1995	Substantially Equivalent	Organon, Inc.
K933524	EXTENTION SET	May 23, 1995	Substantially Equivalent	Mediziv Medical Products 1987 , Ltd.
K950200	IVID	Mar 24, 1995	Substantially Equivalent	Scott/Ross Designs, Inc.
K943992	SILCLEAR TUBING	Mar 16, 1995	Substantially Equivalent	Degania Silicone , Ltd.
K943206	VARIOUS TUBING	Mar 09, 1995	Substantially Equivalent	Prn Services, Inc.
K945184	INTRAVASCULAR ADMINISTRATION SET	Feb 08, 1995	Substantially Equivalent	Distronic Sterile Products, Inc.
K941214	LIFESHIELD EXTENSION SET	Oct 03, 1994	Substantially Equivalent	Abbott Mfg., Inc.
K935642	EVANS MEDICAL EXTENSION SETS	Jan 28, 1994	Substantially Equivalent	Evans Medical, Inc.
K921450	NON-INVASIVE TUBING	Feb 05, 1993	Substantially Equivalent	Specialty Medical Sales, Inc.
K923972	OPHTHALMIC FLUID DISTRIBUTION SETS	Nov 04, 1992	Substantially Equivalent	Visitec Co.
K915560	LO-PROFILE EXTENSION SET	May 14, 1992	Substantially Equivalent	Douglas Medical Products Corp.
K912103	LIFESHIELD EXTENSION SET	Dec 13, 1991	Substantially Equivalent	Abbott Laboratories
K910906	CENTURION KLEEN-NEEDLE SYSTEM I.V. EXTENSION SETS	Apr 01, 1991	Substantially Equivalent	Tri-State Hospital Supply Corp.
K891009	INTRAVASCULAR ADMINISTRATION SET MODEL 60040	May 16, 1989	Substantially Equivalent	3M Company
K891005	INTRAVASCULAR ADMINI. SET MODELS 60030 & 60050	May 11, 1989	Substantially Equivalent	3M Company
K883718	MERIT HI-FLEX(TM)	Jan 30, 1989	Substantially Equivalent	Merit Medical Systems, Inc.
K884156	HYPERBARIC INTRAVENOUS INFUSION EXTENSION SET	Nov 14, 1988	Substantially Equivalent	Sechrist Industries, Inc.
K884370	CMS IV EXTENSION SETS	Nov 07, 1988	Substantially Equivalent	Churchill Medical Systems, Inc.
K875186	IV EXTENSION SET	Feb 16, 1988	Substantially Equivalent	Marquette Medical, Inc.
K873465	VAN DELLEN BACTERIA FILTER	Jan 20, 1988	Substantially Equivalent	Van Dellen, Ltd.
K873852	INFUSION MANIFOLD	Nov 23, 1987	Substantially Equivalent	Advanced Surgical Products, Inc.
K874360	PLASTIC TUBING CONNECTOR	Nov 17, 1987	Substantially Equivalent	American Medical Technology, Inc.
K871085	EXTENSION TUBE PUMP SET	Jun 15, 1987	Substantially Equivalent	Churchill Corp.
K871540	SWIVEL CONNECTORS #014452/#014453/#014459-120	Apr 30, 1987	Substantially Equivalent	Clinical Connections, Inc.
K870416	LP EXTENSION SETS	Apr 06, 1987	Substantially Equivalent	North Coast Medi-Tek
K870912	T-CONNECTORS 014500/014501/014502/014503-120	Mar 17, 1987	Substantially Equivalent	Clinical Connections, Inc.
K870326	VARIOUS LUER AND TUBING FITTINGS	Feb 10, 1987	Substantially Equivalent	Clinical Connections, Inc.
K864692	EXTENSION SETS	Dec 18, 1986	Substantially Equivalent	Salt Creek Medical Technologies
K864395	LOW VOLUME EXTENSION SET	Dec 16, 1986	Substantially Equivalent	Panamedix, Inc.
K861626	CHURCHILL EXTENSION TUBE	Jun 02, 1986	Substantially Equivalent	Churchill Corp.
K854629	CHURCHILL-H EXTENSION TUBE	Dec 10, 1985	Substantially Equivalent	Churchill Corp.
K834164	SPINAL NEEDLES & ACCESSORY	Dec 13, 1983	Substantially Equivalent	Elfa Trading Co.
K833659	IV EXTENSION SET	Nov 29, 1983	Substantially Equivalent	Dna Medical, Inc.
K833076	C-FLEX MEDICAL GRADE TUBING	Nov 21, 1983	Substantially Equivalent	Concept, Inc.
K832758	RED COLOR-TINTED TUBING	Sep 12, 1983	Substantially Equivalent	Custom Medical, Inc.
K820527	ANESTHESIA EXTENSION TUBES	Mar 18, 1982	Substantially Equivalent	David Simmonds Co., Inc.
K812981	FLUVEN SETS (EXT-1, EXT-2, EXT-3, EXT-4)	Nov 06, 1981	Substantially Equivalent	Venusa , Ltd.
K811847	SEA MEDICAL PRODUCTS LO-VOL	Jul 13, 1981	Substantially Equivalent	Sea Medical Products, Inc.
K810005	SAFEED EXTENSION TUBES	Feb 05, 1981	Substantially Equivalent	Terumo Medical Corp.
K800879	CLEAR PLASTIC CONNECTING TUBES	Jun 17, 1980	Substantially Equivalent	Harvard Laboratories
K800877	ANESTHESIA EXTENSION TUBES	Jun 17, 1980	Substantially Equivalent	Harvard Laboratories
K800825	EXTENSION SET QUEST CODE #3000	May 14, 1980	Substantially Equivalent	Quest Medical, Inc.
K781087	MEDICAL GRADE SILICONE ELASTOMER TUBING	Nov 22, 1978	Substantially Equivalent	Mcghan Medical Corp.
K780673	CENTRAL CATHETER KIT	May 16, 1978	Substantially Equivalent	Argon Medical Corp.
K780396	NASAL GASTRIC TUBE RETAINER	Mar 22, 1978	Substantially Equivalent	Mor-Mac, Inc.
K772119	TIME WATCH	Nov 14, 1977	Substantially Equivalent	Akzona, Inc.
K771269	BLOOD COLLECTION SET TYPE H	Sep 12, 1977	Substantially Equivalent	Berman, Pcp & Consultants, Inc.
K771387	MONITORING LINES & FLUID ADMIN.	Aug 22, 1977	Substantially Equivalent	Norton Performance Plastics Corp.
K770945	POUCH, TYVEK-POLYMYLON	Jun 29, 1977	Substantially Equivalent	Medical Disposables Intl., Inc.
K770596	CONNECTORS	Jun 20, 1977	Substantially Equivalent	Abco Dealers, Inc.
K770174	LUER-LOCK EXTENSION SET	Mar 30, 1977	Substantially Equivalent	American Viggo
K770108	TUBE HOLDING DEVICE	Mar 10, 1977	Substantially Equivalent	Pharmaseal Div., Baxter Healthcare Corp.