510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K080448Substantially Equivalent

Centurion Protective Restraint, Scr Series

Centurion Medical Products, LP, Howell MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080448 is the FDA 510(k) clearance record for CENTURION PROTECTIVE RESTRAINT, SCR SERIES, a class I device, cleared for Tri-State Hospital Supply Corp. on under FDA product code FMQ (Restraint, Protective). FDA records list 19 510(k) clearances for CENTURION MEDICAL PRODUCTS, LP, from to . As of , FDA records show no recalls naming K080448.

Clearance record

Decision date
Received
(191 days to decision)
Product code
FMQ Restraint, Protective
Regulation
21 CFR 880.6760
Device class
Class I
Review panel
General Hospital
Applicant
Tri-State Hospital Supply Corp. 301 Catrell Dr., Howell MI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FMQ

Trailing 12 months

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

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