Cleared Traditional

K982822 - FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER MODEL 4C7701, FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER SET MODEL 4C72

K982822 is an FDA 510(k) clearance for FENWAL 20 MICRON PEDIATRIC TRANSFUSION ..., 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 50-day FDA review.

K982822 · Baxter Healthcare Corp · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1998
Decision
50d
Days
Class 2
Risk

K982822 is an FDA 510(k) clearance for the FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER MODEL 4C7701, FENWAL 20 MICRON .... 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 September 30, 1998 after a review of 50 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 - K982822

510(k) Number K982822 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1998
Decision Date September 30, 1998
Days to Decision 50 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
79d faster than avg
Panel avg: 129d · This submission: 50d
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 K982822.
HAEMONETICS 40U RBC FILTER BAG
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CHARTER MEDICAL, LTD MP 450 (40 MICRON FILTER)
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FENWAL 40 MICRON TRANSFUSION FILTER
K972159 · Baxter Healthcare Corp · Jul 1997
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