Cleared Traditional

K972123 - PROTECTIVE RESTRAINT MODELS #302

K972123 is an FDA 510(k) clearance for PROTECTIVE RESTRAINT MODELS #302, manufactured by Smith. The device is a Class 1 General Hospital device with product code FMQ cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K972123 · Smith · General Hospital
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Jul 1997
Decision
50d
Days
Class 1
Risk

K972123 is an FDA 510(k) clearance for the PROTECTIVE RESTRAINT MODELS #302,440,750,850,AND905. Classified as Restraint, Protective (product code FMQ), Class I - General Controls.

Submitted by Smith (Crofton, US). The FDA issued a Cleared decision on July 25, 1997 after a review of 50 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 Smith devices

FDA 510(k) Submission Details - K972123

510(k) Number K972123 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1997
Decision Date July 25, 1997
Days to Decision 50 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 129d · This submission: 50d
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 34
Devices cleared under the same product code (FMQ) and FDA review panel - the closest regulatory comparables to K972123.
DEPUY ORTHOTECH HEAVY DUTY VEST RESTRAINT
K971742 · Depuy, Inc. · Jul 1997
PEDIATRIC LIMB HOLDER
K963466 · Deroyal Industries, Inc. · Feb 1997
RESTRICTIVE LIMB HOLDER
K963468 · Deroyal Industries, Inc. · Jan 1997
TUXEDO VEST RESTRAINT
K963474 · Deroyal Industries, Inc. · Jan 1997
DISPOSABLE LIMB HOLDER
K963476 · Deroyal Industries, Inc. · Jan 1997
ROLL BELTS
K963467 · Deroyal Industries, Inc. · Jan 1997