Cleared Traditional

K942699 - AIRFRAME SURGICAL DRAPE SUPPORT

K942699 is an FDA 510(k) clearance for AIRFRAME SURGICAL DRAPE SUPPORT, manufactured by Alpha Surgical, Inc.. The device is a Class 1 General & Plastic Surgery device with product code BWN cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K942699 · Alpha Surgical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1994
Decision
35d
Days
Class 1
Risk

K942699 is an FDA 510(k) clearance for the AIRFRAME SURGICAL DRAPE SUPPORT. Classified as Table And Attachments, Operating-room (product code BWN), Class I - General Controls.

Submitted by Alpha Surgical, Inc. (Eau Claire, US). The FDA issued a Cleared decision on July 13, 1994 after a review of 35 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4950 - 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 Alpha Surgical, Inc. devices

FDA 510(k) Submission Details - K942699

510(k) Number K942699 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1994
Decision Date July 13, 1994
Days to Decision 35 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
80d faster than avg
Panel avg: 115d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

BWN Device Classification - Class 1, General Controls

Product Code BWN Table And Attachments, Operating-room
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4950
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 - BWN Table And Attachments, Operating-room

Devices cleared under the same product code (BWN) and FDA review panel - the closest regulatory comparables to K942699.
BAUMER SURGICAL TABLE
K902865 · Sds Dental, Inc. · Sep 1990
SPINAL SURGERY FRAME
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GUIDE TO THE KNEE
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THE IMMOBILIZER FOR OPEN & ARTHROSCOPIC
K802271 · The Anspach Effort, Inc. · Oct 1980
TECNOL STIRRUPS STRAP
K791859 · Tecnol New Jersey Wound Care, Inc. · Oct 1979