Product Code: BSF FDA class 1 21 CFR 868.5310

Absorber, Carbon-Dioxide

Anesthesiology

The Absorber, Carbon-Dioxide is a device used in anesthesia breathing circuits to chemically absorb and remove exhaled carbon dioxide, allowing the patient to rebreathe anesthetic gases safely. 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 BSF, regulated under 21 CFR 868.5310 in the Anesthesiology specialty.

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FEI Numbers

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Basic Information

Product Code: BSF
Device Class: FDA class 1
Regulation Number: 868.5310
Medical Specialty: Anesthesiology
Review Panel: AN
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

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Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 8 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K951093	KAB SYSTEM	Mar 24, 1995	Substantially Equivalent	King Systems Corp.
K852071	OHMEDA GMS ABOSORBER	Jul 15, 1985	Substantially Equivalent	Ohmeda Medical
K843422	OHMEDA BAIN CIRCUIT ADAPTER GMS ABSOR	Oct 23, 1984	Substantially Equivalent	Ohmeda Medical
K834535	NITROUS OXIDE RECYCLER	Jun 07, 1984	Substantially Equivalent	G & L Unltd.
K833452	OHIO GMS ABSORBER	Nov 29, 1983	Substantially Equivalent	Airco/Ohio Medical Products
K821144	OHIO ABSORBER	May 28, 1982	Substantially Equivalent	Ohio Medical Products
K801255	PENLON JUMBO CARBON DIOXIDE ABSORBER	Jun 04, 1980	Substantially Equivalent	Penlon, Inc.
K760076	ABSORBER, ANESTHESIA CIRCLE SYS, CO2	Jul 16, 1976	Substantially Equivalent	Fraser Sweatman, Inc.