510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K003335Substantially Equivalent

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

Hill-Rom Air-Shields, Hatboro PA / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K003335 is the FDA 510(k) clearance record for RESUSCITAIRE RADIANT WARMER; RESUSCITAIRE BIRTHING ROOM WARMER; RESUSCITAIR WALL MOUNTED RADIANT WARMER, a class II device, cleared for Hill-Rom Air-Shields on under FDA product code FMT (Warmer, Infant Radiant). FDA records list 5 510(k) clearances for Hill-Rom Air-Shields, from to . As of , FDA records show one recall naming K003335.

Clearance record

Decision date
Received
(23 days to decision)
Product code
FMT Warmer, Infant Radiant
Regulation
21 CFR 880.5130
Device class
Class II
Review panel
General Hospital
Applicant
Hill-Rom Air-Shields 330 Jacksonville Rd., Hatboro PA
510(k) summary
Summary
Third party review
No

Clearances, product code FMT

Trailing 12 months

FDA records hold no clearances under product code FMT in the trailing twelve months.

FDA records show no clearances under product code FMT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FMT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260