Cleared Traditional

K951854 - LEONARD ARM - SUPPORT ARM - ENDOSCOPIC ACCESSORY

K951854 is an FDA 510(k) clearance for LEONARD ARM - SUPPORT ARM - ENDOSCOPIC ..., manufactured by Leonard Medical, Inc.. The device is a Class 1 General & Plastic Surgery device with product code FQO cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K951854 · Leonard Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1995
Decision
61d
Days
Class 1
Risk

K951854 is an FDA 510(k) clearance for the LEONARD ARM - SUPPORT ARM - ENDOSCOPIC ACCESSORY. Classified as Table, Operating-room, Ac-powered (product code FQO), Class I - General Controls.

Submitted by Leonard Medical, Inc. (Huntingdon Valley, US). The FDA issued a Cleared decision on June 21, 1995 after a review of 61 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4960 - the FDA general and plastic surgery 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 Leonard Medical, Inc. devices

FDA 510(k) Submission Details - K951854

510(k) Number K951854 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1995
Decision Date June 21, 1995
Days to Decision 61 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 115d · This submission: 61d
Pathway characteristics
Predicate-based equivalence.

FQO Device Classification - Class 1, General Controls

Product Code FQO Table, Operating-room, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4960
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 - FQO Table, Operating-room, Ac-powered

All 18
Devices cleared under the same product code (FQO) and FDA review panel - the closest regulatory comparables to K951854.
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