510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K884847Substantially Equivalent

Mtd Hedrest

Composites Horizons, Inc., Covina CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K884847 is the FDA 510(k) clearance record for MTD HEDREST, a class I device, cleared for Composites Horizons, Inc. on under FDA product code IWY (Holder, Head, Radiographic). FDA records list one 510(k) clearance for Composites Horizons, Inc. As of , FDA records show no recalls naming K884847.

Clearance record

Decision date
Received
(49 days to decision)
Product code
IWY Holder, Head, Radiographic
Regulation
21 CFR 892.1920
Device class
Class I
Review panel
Radiology
Applicant
Composites Horizons, Inc. 1471 Industrial Park St., Covina CA
Third party review
No

Clearances, product code IWY

Trailing 12 months

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

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