510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K904286Substantially Equivalent

Scale-Tronix Incubator Scale Model:4050/modified

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

K904286 is the FDA 510(k) clearance record for SCALE-TRONIX INCUBATOR SCALE MODEL:4050/MODIFIED, a class I device, cleared for Scale-Tronix, Inc. on under FDA product code FRW (Scale, Patient). FDA records list 4 510(k) clearances for Scale-Tronix, Inc., from to . As of , FDA records show no recalls naming K904286.

Clearance record

Decision date
Received
(33 days to decision)
Product code
FRW Scale, Patient
Regulation
21 CFR 880.2720
Device class
Class I
Review panel
General Hospital
Applicant
Scale-Tronix, Inc. P.O. Box 15, Wheaton IL
Third party review
No

Clearances, product code FRW

Trailing 12 months

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

FDA records show no clearances under product code FRW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FRW, 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