Resuscitaire Radiant Warmer; Resuscitaire Birthing Room Warmer; Resuscitair Wall Mounted Radiant Warmer

510(k) K003335

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 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 · Special	NumberK003335	Date17 Nov 2000Cleared	StatusActive

1 recall · FDA

- Terminated Z-1693-2009 FDA Unclassified (pre-2012) initiated 29 Jul 2009
Spark, flame and smoke: A mis-positioned crimp on heater element lead wire resulted in flame and smoke aerating from the top of the warmer assembly.

1 jurisdiction

United States — FDA 510(k) Active

510(k)

510(k) Number: K003335
FDA Product Code: FMT
Models / Variants: Resuscitaire Radiant Warmer
Resuscitaire Birthing Room Warmer
Resuscitair Wall Mounted Radiant Warmer