Cleared Traditional

K971988 - ALLEN, ULTRA AND SMART SOCKETS

K971988 is an FDA 510(k) clearance for ALLEN, manufactured by Allen Medical Systems, Inc.. The device is a Class 1 General & Plastic Surgery device with product code FQO cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K971988 · Allen Medical Systems, Inc. · General & Plastic Surgery device
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Jul 1997
Decision
43d
Days
Class 1
Risk

K971988 is an FDA 510(k) clearance for the ALLEN, ULTRA AND SMART SOCKETS. Classified as Table, Operating-room, Ac-powered (product code FQO), Class I - General Controls.

Submitted by Allen Medical Systems, Inc. (Cleveland, US). The FDA issued a Cleared decision on July 11, 1997 after a review of 43 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 Allen Medical Systems, Inc. devices

FDA 510(k) Submission Details - K971988

510(k) Number K971988 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 1997
Decision Date July 11, 1997
Days to Decision 43 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 115d · This submission: 43d
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 17
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