Cleared Traditional

K952357 - THE HILL ADJUSTABLE PODIATRY MODEL

K952357 is an FDA 510(k) clearance for THE HILL ADJUSTABLE PODIATRY MODEL, manufactured by Hill Laboratories Co.. The device is a Class 1 Physical Medicine device with product code INQ cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K952357 · Hill Laboratories Co. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1995
Decision
70d
Days
Class 1
Risk

K952357 is an FDA 510(k) clearance for the THE HILL ADJUSTABLE PODIATRY MODEL. Classified as Table, Powered (product code INQ), Class I - General Controls.

Submitted by Hill Laboratories Co. (Malvern, US). The FDA issued a Cleared decision on July 6, 1995 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3760 - the FDA physical medicine 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 Hill Laboratories Co. devices

FDA 510(k) Submission Details - K952357

510(k) Number K952357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1995
Decision Date July 06, 1995
Days to Decision 70 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
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: 116d · This submission: 70d
Pathway characteristics
Predicate-based equivalence.

INQ Device Classification - Class 1, General Controls

Product Code INQ Table, Powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3760
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 - INQ Table, Powered

All 48
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