510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K991591Substantially Equivalent

Biothane Patient Restraint

Bioplastics, N. Ridgeville OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K991591 is the FDA 510(k) clearance record for BIOTHANE PATIENT RESTRAINT, a class I device, cleared for Bioplastics on under FDA product code FMQ (Restraint, Protective). FDA records list one 510(k) clearance for Bioplastics. As of , FDA records show no recalls naming K991591.

Clearance record

Decision date
Received
(83 days to decision)
Product code
FMQ Restraint, Protective
Regulation
21 CFR 880.6760
Device class
Class I
Review panel
General Hospital
Applicant
Bioplastics 34655 Mills Rd., N. Ridgeville OH
510(k) summary
Statement
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