Omni Warm Gel Packs

510(k) K936084

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	NumberK936084	Date31 Mar 1994Cleared	StatusActive

6 recalls · 4 ongoing · FDA

4 recalls, same reason
- Ongoing Z-0506-2022 FDA Class II initiated 29 Nov 2021
- Ongoing Z-0509-2022 FDA Class II initiated 29 Nov 2021
- Ongoing Z-0508-2022 FDA Class II initiated 29 Nov 2021
- Ongoing Z-0505-2022 FDA Class II initiated 26 Nov 2021
After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be distributed or sold without new 510(k) clearance.
- Terminated Z-1316-2016 FDA Class II initiated 10 Feb 2016
eValueMed Infant Heel Warmers and eValueMed Infant Transport Mattresses bear no expiration date, nor any warning that product used beyond its expected shelf life may warm to temperature above its specification.
- Terminated Z-0543-2016 FDA Class II initiated 20 Nov 2015
Heel warmers may cause first and second degree burns.

1 jurisdiction

United States — FDA 510(k) Active

510(k)