# K770183: O.22/UM Filterset W/Flashback

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Feb 9, 1977 after 13 days
- Product code: FPB (Filter, Infusion Line)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Nov 24, 2009 · Not classified · Z-1360-2010: Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.

Source page: https://510kreport.com/device/K770183
Methodology: https://510kreport.com/methodology