Atlas FDA

CAK

36 FDA 510(k) clearances · Product code

52 daysmedian time to decision
118 days90th percentile
36clearances measured

FDA profile

Official device name
Microfilter, Blood Transfusion
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5440
Medical specialty
General Hospital
Adverse events (MAUDE)
2021: 18 · 2022: 110 · 2023: 69 · 2024: 19 · 2025: 62 · 2026: 48
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
HAEMONETICS 40U RBC FILTER BAG (K061103)Haemonetics Corp.2006-05-17
SUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT MEDICAL LTD TRANSFUSION FILTER WITH ADMINISTRATION SET (K022477)Summit Medical , Ltd.2002-10-25
NEOCARE 20 MICRON BLOOD FILTER (K000719)Whatman, Inc.2000-05-30
CHARTER MEDICAL, LTD MP 450 (40 MICRON FILTER) (K990310)Charter Medical, Ltd.1999-08-30
FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER MODEL 4C7701, FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER SET MODEL 4C72 (K982822)Baxter Healthcare Corp1998-09-30
FENWAL 40 MICRON TRANSFUSION FILTER (K972159)Baxter Healthcare Corp1997-07-23
ALPHA MICRON 20/40 MICROAGGREGATE FILTER (K970225)Alpha Therapeutic Corp.1997-02-14
PALL SQ40S BLOOD FILTER (SQ40S/SQ40ST) (K960993)Pall Biomedical Products Co.1996-04-22
ALPHA MICRON 20 MICROAGGREGATE FILTER (K955515)Alpha Therapeutic Corp.1996-02-12
SEPACELL(R) PL-5A/10A LEUKOCYTE REMOVAL FILTERS (K904221)Baxter Healthcare Corp1990-10-26
SEPACELL(R) R-200/500 LEUKOCYTE REMOVAL RECIP SETS (K904223)Baxter Healthcare Corp1990-10-26
MODIFIED SEPACELL R-SERIES BLOOD FILTERS (K901887)Asahi Medical Co., Ltd.1990-08-08
SOLCOSEPT(TM) BLOOD TRANSFUSION FILTER (K896203)Solco Basle, Inc.1990-02-01
MODIFIED SEPACELL R-500 AND R-500A BLOOD FILTERS (K896976)Asahi Medical Co., Ltd.1990-01-24
MODIFIED SEPACELL PL-SERIES LEUKOCYTE REMOVAL FILT (K896664)Asahi Medical Co., Ltd.1990-01-24
MICROSEPT 60/20 (K890844)Arbor Technologies, Inc.1989-06-07
SEPACELL R-500 AND SEPACELL R-500A (K873792)Advocacy International, Ltd.1988-01-19
PALL LEUKOCYTE REMOVAL FILTER, PLATELETS (K873667)Pall Biomedical Products Co.1988-01-06
PALL LEUKOCYTE REMOVAL FILTER, BLOOD (K873666)Pall Biomedical Products Co.1988-01-06
RESUBMITTED MICRON TRANSFUSION FILTER (K873873)Travenol Laboratories, S.A.1987-10-22
ERYPUR B (K864636)Organon Teknika Corp.1987-01-14
SWANK BLOOD TRANSFUSION MICRO-FILTER W/STRAIGHT SE (K855064)Cobe Laboratories, Inc.1986-03-12
SEPACELL R-500 & SEPACELL R-500A (K854259)Advocacy International, Ltd.1986-01-08
INTERFACE TRANSFUSION BLOOD FILTER #35 (K851370)Medical, Inc.1985-06-27
20 MICRON HIGH CAPACITY TRANS/FILTER (K830057)Travenol Laboratories, S.A.1983-01-26
HEMA - NV TRANS. BLOOD FILTER 100/800 (K830014)Abbott Laboratories1983-01-17
INTERFACE TRANSFUSION BLOOD FILTER #30 (K823261)Medical, Inc.1983-01-07
PEDIATRIC MICROAGGREGATE BLOOD FILTER (K812874)Abbott Laboratories1981-11-02
HEMA 20 MICRON TRANSFUSION BLOOD FILTER (K812697)Abbott Laboratories1981-10-08
ULTIPOR SQ40S BLOOD TRANSFUSION FILTER (K811985)Pall Biomedical Products Co.1981-07-28
ALPHA MICRON-40 FILTER (K810761)Alpha Therapeutic Corp.1981-06-30
INTERFACE 20 MICRON TRANSFUSION BLD. F. (K810855)Abbott Laboratories1981-04-21
BLOOD FILTER, MICROEMBOLI-ATS-F10 (K780145)Sorensen Research1978-02-02
MICROFILTRATION SET MF10 (K770253)Biotest-Serum-Institut1977-04-05
FILTER, TRANSFUSION BLOOD, INTERSEPT (K760222)Surgikos, Inc.1976-08-06
FILTER, INFUSION BLOOD (1 PFF-100) (K760165)Bentley Laboratories, Inc.1976-08-06

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Every clearance here is in the API, with alerts when new ones post.