Cleared Traditional

K935199 - SURGICAL APPAREL

K935199 is an FDA 510(k) clearance for SURGICAL APPAREL, manufactured by Associated Hospital Services, Inc.. The device is a Class 2 General Hospital device with product code KKY cleared through the Traditional 510(k) pathway after a 338-day FDA review.

K935199 · Associated Hospital Services, Inc. · General Hospital
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Sep 1994
Decision
338d
Days
Class 2
Risk

K935199 is an FDA 510(k) clearance for the SURGICAL APPAREL. Classified as Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction (product code KKY), Class II - Special Controls.

Submitted by Associated Hospital Services, Inc. (New Orleans, US). The FDA issued a Cleared decision on September 30, 1994 after a review of 338 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.3500 - 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Associated Hospital Services, Inc. devices

FDA 510(k) Submission Details - K935199

510(k) Number K935199 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1993
Decision Date September 30, 1994
Days to Decision 338 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
209d slower than avg
Panel avg: 129d · This submission: 338d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KKY Device Classification - Class 2, Special Controls

Product Code KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3500
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction

All 17
Devices cleared under the same product code (KKY) and FDA review panel - the closest regulatory comparables to K935199.
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HTR POLYMER, HTR-MX
K904111 · United States Surgical, A Division of Tyco Healthc · Nov 1990
UHMWPE SURGICAL MESH
K894478 · Biomet, Inc. · Mar 1990
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K781019 · Kimberly-Clark Corp. · Aug 1978