Cleared Traditional

K963199 - HEELBO PELVIC RESTRAINT (FDA 510(k) Clearance)

Class I General Hospital device.

K963199 · Hollister, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1996
Decision
78d
Days
Class 1
Risk

K963199 is an FDA 510(k) clearance for the HEELBO PELVIC RESTRAINT. Classified as Restraint, Protective (product code FMQ), Class I - General Controls.

Submitted by Hollister, Inc. (Libertyville, US). The FDA issued a Cleared decision on November 1, 1996 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 Hollister, Inc. devices

Submission Details

510(k) Number K963199 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1996
Decision Date November 01, 1996
Days to Decision 78 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 128d · This submission: 78d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.