510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K935609Substantially Equivalent

4002 Infant Scale for Incubators and Warmers

Scale-Tronix, Inc., Wheaton IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K935609 is the FDA 510(k) clearance record for 4002 INFANT SCALE FOR INCUBATORS AND WARMERS, a class II device, cleared for Scale-Tronix, Inc. on under FDA product code FMT (Warmer, Infant Radiant). FDA records list 4 510(k) clearances for Scale-Tronix, Inc., from to . As of , FDA records show no recalls naming K935609.

Clearance record

Decision date
Received
(224 days to decision)
Product code
FMT Warmer, Infant Radiant
Regulation
21 CFR 880.5130
Device class
Class II
Review panel
General Hospital
Applicant
Scale-Tronix, Inc. P.O. Box 15, Wheaton IL
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