# K882594: The Omni-Flow Therapist Infusion Management System

- Pathway: 510(k) (Traditional)
- Applicant: Omni-Flow, Inc.
- Decided: Sep 20, 1988 after 88 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 4 (0 Class I)
- 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. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K033576: Lifeshield Latex-Free Primary IV Pump Set Distal Microbore Patient Line, Convertible Pin, 72 Inch, with 2 Pressure (2003), 0 descendants of its own

## Recalls of this device
- Nov 24, 2009 · Not classified · Z-1342-2010: Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
- Nov 24, 2009 · Not classified · Z-1344-2010: Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
- Nov 24, 2009 · Not classified · Z-1343-2010: Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
- Aug 11, 2009 · Not classified · Z-0020-2010: Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard.

Source page: https://510kreport.com/device/K882594
Methodology: https://510kreport.com/methodology