# K982822: Fenwal 20 Micron Pediatric Transfusion Filter Model 4C7701, Fenwal 20 Micron Pediatric Transfusion Filter Set Model 4C72

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Sep 30, 1998 after 50 days
- Product code: CAK (Microfilter, Blood Transfusion)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K830057 (1983). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K830057: 20 Micron High Capacity Trans/Filter, Travenol Laboratories, S.A. (1983) Summary page 1.
- (no number) Fenwal® 20 Micron Pediatric Transfusion Filter: named in the summary without a submission number

## Indications for use
The Fenwal® 20 Micron Pediatric Transfusion Filter is indicated for the removal of microaggregate particles from whole blood and red blood cells.

Source page: https://510kreport.com/device/K982822
Methodology: https://510kreport.com/methodology