# K033325: Ambit Continuous Ambulatory Infusion Pump

- Pathway: 510(k) (Special)
- Applicant: Sorenson Medical, Inc.
- Decided: Nov 6, 2003 after 21 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
Longest line of descent: 1 generation back to K002434 (2000). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
2 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002434: Palm Pump, Sorenson Medical, Inc. (2000) Summary page 1.

## Most influential descendants
- K140783: Halo Ambulatory Infusion System (2014), 1 descendant of its own
- K153193: Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System) (2016), 0 descendants of its own
- K052221: Ambit Push & Play Ambulatory Infusion Pump (2005), 0 descendants of its own

## Recalls of this device
- Oct 10, 2006 · Not classified · Z-0185-2007: Sterile disposable cassette used with infusion pump may cause an under-infusion when used in a low flow rate therapy of less than 10 ml per hour.
- Oct 10, 2006 · Not classified · Z-0186-2007: Sterile disposable cassette used with infusion pump may cause an under-infusion when used in a low flow rate therapy of less than 10 ml per hour.
- Oct 10, 2006 · Not classified · Z-0188-2007: Sterile disposable cassette used with infusion pump may cause an under-infusion when used in a low flow rate therapy of less than 10 ml per hour.
- Oct 10, 2006 · Not classified · Z-0187-2007: Sterile disposable cassette used with infusion pump may cause an under-infusion when used in a low flow rate therapy of less than 10 ml per hour.

## Indications for use
The amblTrM Infusion Pump is intended for continuous volumetric delivery of intravenous medicines and/or fluids into patients at a consistent volume for prescriptive treatment by a physician.

Source page: https://510kreport.com/device/K033325
Methodology: https://510kreport.com/methodology