Cleared Traditional

K920346 - VARIOUS UTILITY/SURGICAL DRAPE

K920346 is an FDA 510(k) clearance for VARIOUS UTILITY/SURGICAL DRAPE, manufactured by Trinity Laboratories, Inc.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 401-day FDA review.

K920346 · Trinity Laboratories, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1993
Decision
401d
Days
Class 2
Risk

K920346 is an FDA 510(k) clearance for the VARIOUS UTILITY/SURGICAL DRAPE, STERILE, DISPOSABL. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Trinity Laboratories, Inc. (Salisbury, US). The FDA issued a Cleared decision on March 3, 1993 after a review of 401 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4370 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Trinity Laboratories, Inc. devices

FDA 510(k) Submission Details - K920346

510(k) Number K920346 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1992
Decision Date March 03, 1993
Days to Decision 401 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
272d slower than avg
Panel avg: 129d · This submission: 401d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KKX Device Classification - Class 2, Special Controls

Product Code KKX Drape, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4370
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 - KKX Drape, Surgical

All 199
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K920346.
STERILE CONVERTORS SMS POLYPROPYLENE GOWN & DRAPE
K924101 · Baxter Healthcare Corp · Apr 1994
STSTORZ DP5300 AND DP9502 STERILE DRAPES
K934445 · Storz Instrument Co. · Apr 1994
CONTAIN-OR
K934215 · Dlp, Inc. · Feb 1994
COMPEL SURGICAL DRAPES
K923811 · Standard Textile Co., Inc. · Feb 1993
DRAPE UTILITY/SURGICAL STERILE DISPOSABLE
K920284 · Trinity Laboratories, Inc. · Oct 1992
ULCER WOUND TRAY
K922828 · Ulti-Med Intl., Inc. · Sep 1992