510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K950422Substantially Equivalent

First Touch Disposables Temperature Probes

First Touch Disposables, Inc., Wilmington NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K950422 is the FDA 510(k) clearance record for FIRST TOUCH DISPOSABLES TEMPERATURE PROBES, a class II device, cleared for First Touch Disposables, Inc. on under FDA product code FMT (Warmer, Infant Radiant). FDA records list 2 510(k) clearances for First Touch Disposables, Inc., from to . As of , FDA records show no recalls naming K950422.

Clearance record

Decision date
Received
(721 days to decision)
Product code
FMT Warmer, Infant Radiant
Regulation
21 CFR 880.5130
Device class
Class II
Review panel
General Hospital
Applicant
First Touch Disposables, Inc. 3342 Wrightville Ave., Wilmington NC
510(k) summary
Statement
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