# K974661: 0.2 U Bacterial Filter

- Pathway: 510(k) (Traditional)
- Applicant: Sims Deltec, Inc.
- Decided: Feb 11, 1998 after 58 days
- Product code: FPB (Filter, Infusion Line)
- 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Extension Set with microbore tubing and 0.2 u filter: named in the summary without a submission number
- (no number) Disposable I.V. Filter (0.2 n): named in the summary without a submission number

## Most influential descendants
- K181870: Infusion Sets with Precision Filter for Single Use, Precision Infusion Filter for Single Use, Extended Infusion Sets for Single Use (2019), 0 descendants of its own

## Indications for use
The 0.2 p Bacterial Filter can be used with administration sets or extension sets for removal of particulate matter during the administration of fluids or medications.

Source page: https://510kreport.com/device/K974661
Methodology: https://510kreport.com/methodology