Cleared Traditional

K991591 - BIOTHANE PATIENT RESTRAINT

K991591 is an FDA 510(k) clearance for BIOTHANE PATIENT RESTRAINT, manufactured by Bioplastics. The device is a Class 1 General Hospital device with product code FMQ cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K991591 · Bioplastics · General Hospital
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Jul 1999
Decision
83d
Days
Class 1
Risk

K991591 is an FDA 510(k) clearance for the BIOTHANE PATIENT RESTRAINT. Classified as Restraint, Protective (product code FMQ), Class I - General Controls.

Submitted by Bioplastics (N. Ridgeville, US). The FDA issued a Cleared decision on July 29, 1999 after a review of 83 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6760 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bioplastics devices

FDA 510(k) Submission Details - K991591

510(k) Number K991591 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1999
Decision Date July 29, 1999
Days to Decision 83 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 129d · This submission: 83d
Pathway characteristics
Predicate-based equivalence.

FMQ Device Classification - Class 1, General Controls

Product Code FMQ Restraint, Protective
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6760
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - FMQ Restraint, Protective

All 121
Devices cleared under the same product code (FMQ) and FDA review panel - the closest regulatory comparables to K991591.
CENTURION PROTECTIVE RESTRAINT, SCR SERIES
K080448 · Tri-State Hospital Supply Corp. · Aug 2008
INFANT LIMB HOLDER, MODELS 306080 & 306081
K010818 · Skil-Care Corp. · May 2001
CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025
K010644 · Skil-Care Corp. · May 2001
VAGABOND SOFT RESTRAINT SYSTEM
K982178 · Emergent Innovations, Ltd. · Jan 1999
HEELBO WAIST AND CHEST VEST
K980640 · Heelbo, Inc. · May 1998
PEDO CUSH PEDO CUDDLE
K972446 · Cavity Free Kids, Inc. · Nov 1997