Cleared Traditional

K972159 - FENWAL 40 MICRON TRANSFUSION FILTER

K972159 is an FDA 510(k) clearance for FENWAL 40 MICRON TRANSFUSION FILTER, manufactured by Baxter Healthcare Corp. The device is a Class 2 General Hospital device with product code CAK cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K972159 · Baxter Healthcare Corp · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1997
Decision
44d
Days
Class 2
Risk

K972159 is an FDA 510(k) clearance for the FENWAL 40 MICRON TRANSFUSION FILTER. Classified as Microfilter, Blood Transfusion (product code CAK), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on July 23, 1997 after a review of 44 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Baxter Healthcare Corp devices

FDA 510(k) Submission Details - K972159

510(k) Number K972159 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1997
Decision Date July 23, 1997
Days to Decision 44 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 129d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAK Device Classification - Class 2, Special Controls

Product Code CAK Microfilter, Blood Transfusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - CAK Microfilter, Blood Transfusion

All 24
Devices cleared under the same product code (CAK) and FDA review panel - the closest regulatory comparables to K972159.
HAEMONETICS 40U RBC FILTER BAG
K061103 · Haemonetics Corp. · May 2006
CHARTER MEDICAL, LTD MP 450 (40 MICRON FILTER)
K990310 · Charter Medical, Ltd. · Aug 1999
FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER MODEL 4C7701, FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER SET MODEL 4C72
K982822 · Baxter Healthcare Corp · Sep 1998
ALPHA MICRON 20/40 MICROAGGREGATE FILTER
K970225 · Alpha Therapeutic Corp. · Feb 1997
PALL SQ40S BLOOD FILTER (SQ40S/SQ40ST)
K960993 · Pall Biomedical Products Co. · Apr 1996
ALPHA MICRON 20 MICROAGGREGATE FILTER
K955515 · Alpha Therapeutic Corp. · Feb 1996