Product Code: CAK FDA class 2 21 CFR 880.5440

Microfilter, Blood Transfusion

General Hospital

The Blood Transfusion Microfilter is a general hospital device used to remove particulate matter, microaggregates, and debris from blood products during transfusion, reducing the risk of transfusion-related complications. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is CAK, regulated under 21 CFR 880.5440, within the General Hospital medical specialty. No special flags apply to this device.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

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

Device Characteristics

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GMP Exempt

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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 36 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K061103	HAEMONETICS 40U RBC FILTER BAG	May 17, 2006	Substantially Equivalent	Haemonetics Corp.
K022477	SUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT MEDICAL LTD TRANSFUSION FILTER WITH ADMINISTRATION SET	Oct 25, 2002	Substantially Equivalent	Summit Medical , Ltd.
K000719	NEOCARE 20 MICRON BLOOD FILTER	May 30, 2000	Substantially Equivalent	Whatman, Inc.
K990310	CHARTER MEDICAL, LTD MP 450 (40 MICRON FILTER)	Aug 30, 1999	Substantially Equivalent	Charter Medical, Ltd.
K982822	FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER MODEL 4C7701, FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER SET MODEL 4C72	Sep 30, 1998	Substantially Equivalent	Baxter Healthcare Corp
K972159	FENWAL 40 MICRON TRANSFUSION FILTER	Jul 23, 1997	Substantially Equivalent	Baxter Healthcare Corp
K970225	ALPHA MICRON 20/40 MICROAGGREGATE FILTER	Feb 14, 1997	Substantially Equivalent	Alpha Therapeutic Corp.
K960993	PALL SQ40S BLOOD FILTER (SQ40S/SQ40ST)	Apr 22, 1996	Substantially Equivalent	Pall Biomedical Products Co.
K955515	ALPHA MICRON 20 MICROAGGREGATE FILTER	Feb 12, 1996	Substantially Equivalent	Alpha Therapeutic Corp.
K904223	SEPACELL(R) R-200/500 LEUKOCYTE REMOVAL RECIP SETS	Oct 26, 1990	Substantially Equivalent	Baxter Healthcare Corp
K904221	SEPACELL(R) PL-5A/10A LEUKOCYTE REMOVAL FILTERS	Oct 26, 1990	Substantially Equivalent	Baxter Healthcare Corp
K901887	MODIFIED SEPACELL R-SERIES BLOOD FILTERS	Aug 08, 1990	Substantially Equivalent	Asahi Medical Co., Ltd.
K896203	SOLCOSEPT(TM) BLOOD TRANSFUSION FILTER	Feb 01, 1990	Substantially Equivalent	Solco Basle, Inc.
K896976	MODIFIED SEPACELL R-500 AND R-500A BLOOD FILTERS	Jan 24, 1990	Substantially Equivalent	Asahi Medical Co., Ltd.
K896664	MODIFIED SEPACELL PL-SERIES LEUKOCYTE REMOVAL FILT	Jan 24, 1990	Substantially Equivalent	Asahi Medical Co., Ltd.
K890844	MICROSEPT 60/20	Jun 07, 1989	Substantially Equivalent	Arbor Technologies, Inc.
K873792	SEPACELL R-500 AND SEPACELL R-500A	Jan 19, 1988	Substantially Equivalent	Advocacy International, Ltd.
K873667	PALL LEUKOCYTE REMOVAL FILTER, PLATELETS	Jan 06, 1988	Substantially Equivalent	Pall Biomedical Products Co.
K873666	PALL LEUKOCYTE REMOVAL FILTER, BLOOD	Jan 06, 1988	Substantially Equivalent	Pall Biomedical Products Co.
K873873	RESUBMITTED MICRON TRANSFUSION FILTER	Oct 22, 1987	Substantially Equivalent	Travenol Laboratories, S.A.
K864636	ERYPUR B	Jan 14, 1987	Substantially Equivalent	Organon Teknika Corp.
K855064	SWANK BLOOD TRANSFUSION MICRO-FILTER W/STRAIGHT SE	Mar 12, 1986	Substantially Equivalent	Cobe Laboratories, Inc.
K854259	SEPACELL R-500 & SEPACELL R-500A	Jan 08, 1986	Substantially Equivalent	Advocacy International, Ltd.
K851370	INTERFACE TRANSFUSION BLOOD FILTER #35	Jun 27, 1985	Substantially Equivalent	Medical, Inc.
K830057	20 MICRON HIGH CAPACITY TRANS/FILTER	Jan 26, 1983	Substantially Equivalent	Travenol Laboratories, S.A.
K830014	HEMA - NV TRANS. BLOOD FILTER 100/800	Jan 17, 1983	Substantially Equivalent	Abbott Laboratories
K823261	INTERFACE TRANSFUSION BLOOD FILTER #30	Jan 07, 1983	Substantially Equivalent	Medical, Inc.
K812874	PEDIATRIC MICROAGGREGATE BLOOD FILTER	Nov 02, 1981	Substantially Equivalent	Abbott Laboratories
K812697	HEMA 20 MICRON TRANSFUSION BLOOD FILTER	Oct 08, 1981	Substantially Equivalent	Abbott Laboratories
K811985	ULTIPOR SQ40S BLOOD TRANSFUSION FILTER	Jul 28, 1981	Substantially Equivalent	Pall Biomedical Products Co.
K810761	ALPHA MICRON-40 FILTER	Jun 30, 1981	Substantially Equivalent	Alpha Therapeutic Corp.
K810855	INTERFACE 20 MICRON TRANSFUSION BLD. F.	Apr 21, 1981	Substantially Equivalent	Abbott Laboratories
K780145	BLOOD FILTER, MICROEMBOLI-ATS-F10	Feb 02, 1978	Substantially Equivalent	Sorensen Research
K770253	MICROFILTRATION SET MF10	Apr 05, 1977	Substantially Equivalent	Biotest-Serum-Institut
K760222	FILTER, TRANSFUSION BLOOD, INTERSEPT	Aug 06, 1976	Substantially Equivalent	Surgikos, Inc.
K760165	FILTER, INFUSION BLOOD (1 PFF-100)	Aug 06, 1976	Substantially Equivalent	Bentley Laboratories, Inc.