Atlas FDA

HEMA - NV TRANS. BLOOD FILTER 100/800

FDA 510(k) clearance K830014 · decided 1983-01-17

Clearance details

K-number
K830014
Device name
HEMA - NV TRANS. BLOOD FILTER 100/800
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
1983-01-03
Decision date
1983-01-17
Days to decision
14 days
Clearance type
Traditional
Product code
CAK
Device class
2
Regulation number
880.5440
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Abbott Park, IL, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

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

Recalls involving this device

RecordFirmDate
LifeShield Latex-Free Primary I.V. Pump Set with Distal Microbore Patient Line and Gravity recall (Z-0542-2007)Hospira Inc.2007-02-27
Hospira Latex Free Blood Secondary Set, 26 inch with Secure Lock; Made in Costa Rica, Hosp recall (Z-0504-06)Hospira Inc.2006-02-08
LifeShield Latex-Free HEMA Blood PlumSet, Nonvented, 110 Inch with 210 Micron Filter, Prep recall (Z-0195-06)Hospira Inc.2005-11-24
LifeShield Latex-Free HEMA Blood PlumSet; Nonvented, 100 inch, with 210 Micron Filter, Pre recall (Z-0133-06)Hospira Inc.2005-11-15
LifeShield Latex-Free HEMA Y-Type Blood PlumSet, Nonvented, 122 inch, with 210 Micron Filt recall (Z-0134-06)Hospira Inc.2005-11-15
LifeShield Latex-Free HEMA Y-Type Blood PlumSet, Nonvented, 122 inch, with 210 Micron Filt recall (Z-0135-06)Hospira Inc.2005-11-15

PMA approvals by this applicant

RecordFirmDate
ARCHITECT CORE / Alinity i Anti-HBc (P080023/S046)Abbott Laboratories2025-04-03
ARCHITECT AFP / Alinity i AFP (P120008/S030)Abbott Laboratories2025-04-03
ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S043)Abbott Laboratories2025-04-03
ARCHITECT Total PSA / Alinity i Total PSA (P910007/S066)Abbott Laboratories2025-04-03
ARCHITECT Free PSA / Alinity i Free PSA (P980007/S055)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S052)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory/ Alinity i HBsAg Next Qualitative/Alinity i HBsAg N (P210003/S013)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory (P210003/S012)Abbott Laboratories2024-09-30