Kendall Epump Enteral Feeding Pump and Enteral Feeding Sets

510(k) K040196

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

This device is named in the recall

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK040196	Date5 May 2004Cleared	StatusActive

5 recalls · 4 ongoing · FDA

4 recalls, same reason
- Ongoing Z-2103-2020 FDA Class II initiated 26 Dec 2019
- Ongoing Z-2100-2020 FDA Class II initiated 26 Dec 2019
- Ongoing Z-2104-2020 FDA Class II initiated 26 Dec 2019
- Ongoing Z-2101-2020 FDA Class II initiated 26 Dec 2019
The feeding spike sets may leak at the interface of the tube and spike connector.
- Completed Z-1347-2021 FDA Class II initiated 19 Jan 2021
The potential for air appearing in the enteral feed pumping set tubing during set-up.

1 jurisdiction

United States — FDA 510(k) Active

510(k)