# K991501: Acclaim Infusion Pump

- Pathway: 510(k) (Special)
- Applicant: Abbott Laboratories
- Decided: May 13, 1999 after 14 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
3 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K100705: Zyno Z-800 Infusion System Model Z-800 (2010), 1 descendant of its own
- K130690: Z-800 Infusion System (2013), 0 descendants of its own

## Recalls of this device
- Oct 31, 2013 · Class I · Z-1482-2014: Hospira has received customer reports of broken door assemblies on the Hospira/Abbott Acclaim Encore infusion pumps. If the door assembly breaks, it may prevent the door from closing properly and unre

## Indications for use
The subject device is intended for intravenous fluid, blood and blood products, short-term epidural administration not exceeding 96 hours, and for delivery of enteral feeding solutions to patients in hospital and home care environments.

Source page: https://510kreport.com/device/K991501
Methodology: https://510kreport.com/methodology