Product Code: CBT FDA class 1 21 CFR 868.1100

Arterial Blood Sampling Kit

Anesthesiology

The Arterial Blood Sampling Kit is a convenience kit used in anesthesiology containing the components needed to collect arterial blood samples for blood gas analysis, typically including a syringe, needle, and related accessories. Per the FDA's May 1997 Convenience Kits Interim Regulatory Guidance, this type of kit is under enforcement discretion and does not require a 510(k) premarket notification if it meets all criteria in that guidance. It is classified as FDA Class 1 (lowest risk). The product code is CBT, regulated under 21 CFR 868.1100, within the Anesthesiology medical specialty.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

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Basic Information

Product Code: CBT
Device Class: FDA class 1
Regulation Number: 868.1100
Medical Specialty: Anesthesiology
Review Panel: AN
Submission Type: 7

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

Definition

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 58 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K071269	HEMODRAW ARTERIAL BLOOD SAMPLING SYSTEM	Aug 01, 2007	Substantially Equivalent	Smiths Medical Asd, Inc.
K070340	SECURE ARTERIAL BLOOD SAMPLING SYSTEM	Mar 15, 2007	Substantially Equivalent	Smiths Medical Asd, Inc.
K955663	ABC IN-LINE BLOOD SAMPLING KIT	Mar 17, 1997	Substantially Equivalent	Utah Medical Products, Inc.
K954015	ABG POINT LOK NEEDLE PROTECTION DEVICE	Nov 20, 1995	Substantially Equivalent	Devon Industries, Inc.
K954035	ACTI-FLEX ARTERIAL EXTENSION SET	Sep 25, 1995	Substantially Equivalent	R-Group Intl.
K950098	NEEDLE SAFETY COVER	Aug 11, 1995	Substantially Equivalent	Hammer-Plane, Inc.
K945719	ASPIR-PULSE(TM) ARTERIAL BLOOD GAS (ABG) SYSTEM	Mar 16, 1995	Unknown	Sherwood Medical Co.
K944941	PISTON SYRINGE	Dec 05, 1994	Substantially Equivalent	Martell Medical Products, Inc.
K945485	ABG NEEDLE PROTECTION	Nov 29, 1994	Substantially Equivalent	Devon Industries, Inc.
K940575	ASPIR-PULSE(TM) SAF-T-VENT	Mar 22, 1994	Substantially Equivalent	Sherwood Medical Co.
K931873	VACVENT	Dec 30, 1993	Unknown	Steven Frank Mercereau
K930986	BLOOD GAS KIT (NON-STERILE) REORDER NO. 0560	Jul 14, 1993	Unknown	Customed, Inc.
K925453	SHERWOOD MEDICAL ARTERIAL BLOOD GAS KIT I	Jul 12, 1993	Unknown	Sherwood Medical Co.
K930471	SHERWOOD MEDICAL ARTERIAL BLOOD GAS KIT II	Jun 22, 1993	Unknown	Sherwood Medical Co.
K930286	DRI-VENDT/PROVENT/ACCUVENT ARTERIAL BLOOD GAS KITS	Jun 22, 1993	Unknown	Concord/Portex
K914778	NEOLINE(TM)	Sep 16, 1992	Unknown	Martech Medical Products, Inc.
K912043	ACCU-VENT(TM) WITH NEEDLE-PRO(TM)	Jul 05, 1991	Unknown	Concord/Portex
K905464	MEDICAL PROCEDURE KITS/ARTERIAL BLOOD SAMPLING	May 31, 1991	Unknown	Angiosystems, Inc.
K902881	LAB-SITE SAFETY NEEDLE	Sep 26, 1990	Substantially Equivalent	Migada, Ltd.
K902632	GAS-LYTE 1CC AND 3CC ARTERIAL BLOOD SAMPLERS	Sep 04, 1990	Substantially Equivalent	Marquest Medical Products, Inc.
K900302	UMBILICAL CORD BLOOD SAMPLING KIT	Apr 10, 1990	Substantially Equivalent	Ge Medical Systems Information Technologies
K897133	MODEL 1050 - UMBILICAL CORD BLOOD SAMPLING KIT	Mar 30, 1990	Substantially Equivalent	Transidyne General Corp.
K895171	BLOOD GAS SAFETY SYRINGE	Nov 07, 1989	Substantially Equivalent	Kronner Medical
K875117	CIBA CORNING BALANCED HEPARIN FOR CA++	Feb 29, 1988	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K872244	CORD-ASSURE UMBILICAL BLOOD GAS KIT	Jul 21, 1987	Substantially Equivalent	Lake Medical Products, Inc.
K870720	AIRLIFE ARTERIAL BLOOD GAS SAMPLING SYRINGE	Mar 17, 1987	Substantially Equivalent	American Pharmaseal Div. Ahsc
K844615	BIOSAMPLER	Mar 21, 1985	Substantially Equivalent	Biotek-Caribbean
K843360	ARTAP ARTERIAL BLOOD SAMPLING DEVICE	Oct 31, 1984	Substantially Equivalent	Analytical Products, Inc.
K842008	MARQUEST MICRO STIK 9000 SERIES	May 25, 1984	Substantially Equivalent	Marquest Medical Products, Inc.
K841486	ARTERIAL BLOOD SAMPLING KITS	May 23, 1984	Substantially Equivalent	Concord Laboratories, Inc.
K840987	VAPORIZED HEPARIN	Apr 05, 1984	Substantially Equivalent	Concord Laboratories, Inc.
K840986	PREFILLED PULSATOR SYRINGE	Apr 05, 1984	Substantially Equivalent	Concord Laboratories, Inc.
K833923	MARZ-175 ARTERIAL BLOOD GAS SYRINGE	Jan 09, 1984	Substantially Equivalent	Chesebrough-Pond'S U.S.A. Co.
K833582	PULSATOR ARTERIAL BLOOD SAMPLING SYRIN	Dec 27, 1983	Substantially Equivalent	Concord Laboratories, Inc.
K832545	ARTERIAL BLOOD SAMPLING KIT	Sep 26, 1983	Substantially Equivalent	Dhd Medical Products Div. Diemolding Corp.
K830312	ASPIRATOR	May 25, 1983	Substantially Equivalent	Marquest Medical Products, Inc.
K830311	AUTO STIK	May 25, 1983	Substantially Equivalent	Marquest Medical Products, Inc.
K830310	OMNISTICK	May 25, 1983	Substantially Equivalent	Marquest Medical Products, Inc.
K831034	QUALISTICK ARTERIAL BLOOD SAMPLER	May 18, 1983	Substantially Equivalent	Radiometer America, Inc.
K830333	ABG KITS - CMS 4000 SERIES	Mar 31, 1983	Substantially Equivalent	Currie Medical Specialties, Inc.
K822786	MDM ARTERIAL BLOOD GAS KIT	Oct 21, 1982	Substantially Equivalent	Martell Medical Products, Inc.
K822248	DESERET ARTERIAL BLOOD SAMPLING KIT	Oct 21, 1982	Substantially Equivalent	Warner-Lambert Co.
K821406	ARTERIAL BLOOD SAMPLING KIT	Jun 25, 1982	Substantially Equivalent	Dhd Medical Products Div. Diemolding Corp.
K820875	AUTOSTIK	May 07, 1982	Substantially Equivalent	Marquest Medical Products, Inc.
K812338	PREZA-PAK II, ARTERIAL BLOOD SAMPLING SY	Sep 23, 1981	Substantially Equivalent	Terumo Medical Corp.
K811860	EASY-FLO ARTERIAL BLOOD GAS KIT	Jul 16, 1981	Substantially Equivalent	Dhd Medical Products Div. Diemolding Corp.
K811199	MARZ-175	May 21, 1981	Substantially Equivalent	Emde Corp.
K801620	ASPIRATOR	Jul 21, 1980	Substantially Equivalent	Marquest Medical Products, Inc.
K801435	ORGANON ARTERIAL BLOOD SAMPLER	Jul 18, 1980	Substantially Equivalent	Akzona, Inc.
K801146	SAMPLING KIT	Jun 04, 1980	Substantially Equivalent	Pharmaseal Laboratories
K800860	OMNISTIK, MQ 501GS	Apr 29, 1980	Substantially Equivalent	Marquest Medical Products, Inc.
K791465	MOSQUITO ARTERIAL BLOOD SAMPLER	Sep 17, 1979	Substantially Equivalent	Emde Corp.
K790196	MONOJECT ARTERIAL BLOOD SAMPLING DEVICE	Mar 13, 1979	Substantially Equivalent	Sherwood Medical Industries
K781857	TRAY, ARTERIAL BLOOD GAS SAMPLING	Dec 11, 1978	Substantially Equivalent	Jelco Laboratories
K781616	OMNI STIK	Dec 08, 1978	Substantially Equivalent	Unitron Corp.
K780939	BARD-PARKER ARTERIAL MONITORING SYSTEM	Jul 17, 1978	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K771975	ARTERIAL BLOOD SAMPLING TRAY	Oct 28, 1977	Substantially Equivalent	Respiratory Care, Inc.
K771013	MOSQUITO	Jul 01, 1977	Substantially Equivalent	Emde Corp.