Med-Rx Pediatric Feeding Tubes and Accessories

510(k) K100700

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

6 closed

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	NumberK100700	Date13 Dec 2010Cleared	StatusActive

6 recalls · FDA

- Terminated Z-2293-2019 FDA Class II initiated 22 Jul 2019
Certain MED-RX Polyurethane Feeding Tubes are being recalled due to a product concern where the connector has detached from the feeding tube.
- Terminated Z-2281-2019 FDA Class II initiated 16 Jul 2019
The firm received a complaint that the connector detached from the feeding tube.
- Terminated Z-0746-2019 FDA Class II initiated 17 Dec 2018
Enteral Safe Feeding Tubes labeled as 6.5 FR X 24" contained 5 FR X 24" Enteral Safe Feeding Tubes.
- Terminated Z-0725-2019 FDA Class II initiated 1 Dec 2018
The product may be packaged with a 5FR X 24 length Feeding tube instead of a 6.5 FR X 24 Feeding tube as labeled.
- Terminated Z-2440-2018 FDA Class II initiated 11 Jun 2018
The product may be packaged with the incorrect length of feeding tube as labeled.
- Terminated Z-0595-2016 FDA Class II initiated 11 Dec 2015
The product may be packaged with a 5 or 6.5FR tube instead of an 8FR size.

1 jurisdiction

United States — FDA 510(k) Active

510(k)