# K033425: Ambit Intermittent Ambulatory Infusion Pump

- Pathway: 510(k) (Special)
- Applicant: Sorenson Medical, Inc.
- Decided: Nov 6, 2003 after 10 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 1 (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.
No later device cites it as a predicate yet.
0 of 2 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). Our reading of the summary gave K002334, FDA’s number for Macroporens Craniloc (Macropore Biosurgery, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Palm Pump”. Summary page 1.

## Recalls of this device
- May 3, 2006 · Not classified · Z-1188-06: Intermittent Infusion pump may continually dispense medication under certain conditions.

## Indications for use
The ambIT™ Intermittent Ambulatory Infusion Pump is intended for the Intermittent volumetric delivery of intravenous medicines and/or fluids into patients at predetermined rates and volumes for prescriptive treatment by a physician.

Source page: https://510kreport.com/device/K033425
Methodology: https://510kreport.com/methodology