# K052773: B. Braun 0.2 Micron Filter

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Jan 24, 2006 after 113 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- 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 K952918 (1995). 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)
- K952918: Ptfe Syringe Filter, B.Braun Medical, Inc. (1995) Summary page 1.

## Indications for use
The B. Braun 0.2 micron Filter is intended to filter particulates from drug solutions when attached to a syringe prior to patient administration.

Source page: https://510kreport.com/device/K052773
Methodology: https://510kreport.com/methodology