Cleared Traditional

K970272 - PATIENT RESTRAINT

K970272 is an FDA 510(k) clearance for PATIENT RESTRAINT, manufactured by Fla Orthopedics, Inc.. The device is a Class 1 General Hospital device with product code FMQ cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K970272 · Fla Orthopedics, Inc. · General Hospital
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Apr 1997
Decision
78d
Days
Class 1
Risk

K970272 is an FDA 510(k) clearance for the PATIENT RESTRAINT. Classified as Restraint, Protective (product code FMQ), Class I - General Controls.

Submitted by Fla Orthopedics, Inc. (Miami Lakes, US). The FDA issued a Cleared decision on April 11, 1997 after a review of 78 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 Fla Orthopedics, Inc. devices

FDA 510(k) Submission Details - K970272

510(k) Number K970272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1997
Decision Date April 11, 1997
Days to Decision 78 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
51d faster than avg
Panel avg: 129d · This submission: 78d
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 66
Devices cleared under the same product code (FMQ) and FDA review panel - the closest regulatory comparables to K970272.
PROTECTIVE RESTRAINT(MODELS #302,440,750 AND A30 X 30 BELT.
K972338 · Geriatric Products, Inc. · Jul 1997
PROVEST-PROTECTIVE RESTRAINT
K971561 · Jemm Medical Products · Jul 1997
RESTRAINTS (VESTS AND JACKETS)
K971536 · E.M. Adams Co., Inc. · Jul 1997
PATIENT RESTRAINTS
K970273 · Fla Orthopedics, Inc. · Apr 1997
PATIENT RESTRAINTS
K970274 · Fla Orthopedics, Inc. · Apr 1997
PATIENT RESTRAINTS
K970275 · Fla Orthopedics, Inc. · Apr 1997