Product Code: KRJ FDA class 2 21 CFR 870.4280

Filter, Prebypass, Cardiopulmonary Bypass

Cardiovascular

This device is a prebypass filter used in cardiopulmonary bypass circuits to remove particulates and air from the priming solution before it enters the patient's circulation at the start of bypass surgery, reducing the risk of embolic complications. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is KRJ, regulated under 21 CFR 870.4280 within the Cardiovascular specialty. No special flags apply.

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510(k)s

FEI Numbers

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Basic Information

Product Code: KRJ
Device Class: FDA class 2
Regulation Number: 870.4280
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 4

Device Characteristics

✗

GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 24 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K990276	POROUS MEDIA DPB30 SERIES DISPOSABLE PRE-BYPASS FILTER	Oct 01, 1999	Substantially Equivalent	Porous Media Corp.
K982385	POROUS MEDIA DPB20 SERIES DISPOSABLE PRE-BYPASS FILTER	Feb 01, 1999	Substantially Equivalent	Porous Media Corp.
K940126	AVECOR PRE-BYPASS FILTER	Jun 28, 1994	Substantially Equivalent	Avecor Cardiovascular, Inc.
K900672	PREBYPASS FILTER, CAT. NO. FPB-5	Apr 03, 1990	Substantially Equivalent	American Omni Medical, Inc.
K885154	INTERSEPT* CRYSTALLOID CARDIOPLEGIA DELIV. SYSTEM	Feb 22, 1989	Substantially Equivalent	Medtronic Blood Systems, Inc.
K884390	INTERSEPT* CRYSTALLOID CARDIOPLEGIA FILTER	Dec 21, 1988	Substantially Equivalent	Medtronic Blood Systems, Inc.
K884244	INTERSEPT* PREBYPASS FILTER	Dec 05, 1988	Substantially Equivalent	Medtronic Blood Systems, Inc.
K883086	INTERSEPT*PREBYPASS FILTER	Sep 16, 1988	Substantially Equivalent	Medtronic Blood Systems, Inc.
K875094	ULTIPOR PRE-BYPASS PLUS FILTER W/POSIDYNE MEMBRANE	Feb 29, 1988	Substantially Equivalent	Pall Biomedical Products Co.
K871350	PREBYPASS FILTER	Jun 08, 1987	Substantially Equivalent	American Omni Medical, Inc.
K861226	INTERFACE CRYSTALLOID CARDIOPLEGIC FILTER MODEL 70	Jun 02, 1986	Substantially Equivalent	Medical, Inc.
K850139	COBE COP FILTER CARDIOPULMONARY PREBYPASS FILTER	Apr 10, 1985	Substantially Equivalent	Rapid Diagnostic Laboratories, Inc.
K842141	SOLUTION CLARIFICATION UNIT	Aug 03, 1984	Substantially Equivalent	Pall Biomedical Products Co.
K840450	SHILEY PREBYPASS FILTER	Apr 17, 1984	Substantially Equivalent	Shiley, Inc.
K832594	PRE-BYPASS FILTER #EC-PBF SERIES	Sep 20, 1983	Substantially Equivalent	Gish Biomedical, Inc.
K831286	ULTIPORE PREBYPASS PLUS FILTER	Jun 08, 1983	Substantially Equivalent	Pall Biomedical Products Co.
K812539	PRE-BYPASS FILTER	Oct 13, 1981	Substantially Equivalent	Gelman Sciences, Inc.
K812244	INTERFACE PRE BYPASS PRIME FILTER #90	Aug 25, 1981	Substantially Equivalent	Medical, Inc.
K812240	INTERFACE PRE BYPASS PRIME FILTER	Aug 25, 1981	Substantially Equivalent	Medical, Inc.
K810395	PRE-BYPASS FILTER	Mar 05, 1981	Substantially Equivalent	Texas Medical Products, Inc.
K803101	PREBYPASS FILTER CAT.#K-5	Dec 22, 1980	Substantially Equivalent	Delta Medical Industries
K800135	CARDIOPLEGIA ADMINISTRATION SYSTEM CAS	Feb 01, 1980	Substantially Equivalent	Bentley Laboratories, Inc.
K790361	RECIRCULATION FILTER MODEL RF-10	Mar 28, 1979	Substantially Equivalent	Bentley Laboratories, Inc.
K780485	PREBYPASS FILTER	Apr 05, 1978	Substantially Equivalent	Delta Medical Industries