# K162165: ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump

- Pathway: 510(k) (Traditional)
- Applicant: Summit Medical Products, Inc.
- Decided: Aug 29, 2017 after 391 days
- Product code: MEA (Pump, Infusion, Pca)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 5 (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) Summary page 4.

## Recalls of this device
- Apr 24, 2023 · Class II · Z-1688-2023: Some of the ambIT kits were potentially distributed without an air in-line filter.
- Apr 24, 2023 · Class II · Z-1687-2023: Some of the ambIT kits were potentially distributed without an air in-line filter.
- Apr 24, 2023 · Class II · Z-1684-2023: Some of the ambIT kits were potentially distributed without an air in-line filter.
- Apr 24, 2023 · Class II · Z-1686-2023: Some of the ambIT kits were potentially distributed without an air in-line filter.
- Apr 24, 2023 · Class II · Z-1685-2023: Some of the ambIT kits were potentially distributed without an air in-line filter.

## Indications for use
The ambIT PCA*PIB Pump is used to infuse medicines and/or fluids into patients primarily for pain management. The routes of administration are generally intravenous, epidural and/or regional. The ambIT PCA*PIB Pump is not intended to supersede, augment, or replace any other medical device or drug indications for use or intended uses. The ambIT PCA*PIB Pump is intended to be used in the home and in healthcare facilities.

Source page: https://510kreport.com/device/K162165
Methodology: https://510kreport.com/methodology