510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K925145Substantially Equivalent

Trace Model #'S 840, 841, 842, 845

Trace Medical Equipment, Inc., Lisle IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K925145 is the FDA 510(k) clearance record for TRACE MODEL #'S 840, 841, 842, 845, a class I device, cleared for Trace Medical Equipment, Inc. on under FDA product code FYH (Splint, Extremity, Noninflatable, External, Sterile). FDA records list 2 510(k) clearances for Trace Medical Equipment, Inc., from to . As of , FDA records show no recalls naming K925145.

Clearance record

Decision date
Received
(218 days to decision)
Product code
FYH Splint, Extremity, Noninflatable, External, Sterile
Regulation
21 CFR 878.3910
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Trace Medical Equipment, Inc. 5000 Varsity Dr., Lisle IL
510(k) summary
Statement
Third party review
No

Clearances, product code FYH

Trailing 12 months

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

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