# K052221: Ambit Push & Play Ambulatory Infusion Pump

- Pathway: 510(k) (Abbreviated)
- Applicant: Sorenson Medical, Inc.
- Decided: Dec 8, 2005 after 115 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: 2 generations back to K002434 (2000). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K965222: Microject Model Pca-1, Microject, Inc. (1997) Summary page 1.
- K002434: Palm Pump, Sorenson Medical, Inc. (2000) Summary page 1.
- K033325: Ambit Continuous Ambulatory Infusion Pump, Sorenson Medical, Inc. (2003) Summary page 1.
- K042405: PAINPUMP1; PAINPUMP2, Stryker Corp. (2004) Summary page 1.

## 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 ambIT® "PreSet" Ambulatory Infusion Pump is intended for use by surgeons and anesthesiologists for the perioperative and post operative infusion of local anesthetics and narcotics for pain management and regional anesthesia. Routes of administration include intravenous, subcutaneous, intramuscular, perineural and epidural. The ambIT® "PreSet" Ambulatory Infusion Pump is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to surgical wound sites or close proximity to nerves when compared with narcotic only pain management.

Source page: https://510kreport.com/device/K052221
Methodology: https://510kreport.com/methodology