Cleared Traditional

K922918 - BARRIER SAF-TE HYDROGEL DRAPE

K922918 is an FDA 510(k) clearance for BARRIER SAF-TE HYDROGEL DRAPE, manufactured by Johnson & Johnson International. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 383-day FDA review.

K922918 · Johnson & Johnson International · General Hospital
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Jul 1993
Decision
383d
Days
Class 2
Risk

K922918 is an FDA 510(k) clearance for the BARRIER SAF-TE HYDROGEL DRAPE. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Johnson & Johnson International (Arlington, US). The FDA issued a Cleared decision on July 6, 1993 after a review of 383 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: 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 Johnson & Johnson International devices

FDA 510(k) Submission Details - K922918

510(k) Number K922918 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1992
Decision Date July 06, 1993
Days to Decision 383 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
254d slower than avg
Panel avg: 129d · This submission: 383d
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 238
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K922918.
STSTORZ DP5300 AND DP9502 STERILE DRAPES
K934445 · Storz Instrument Co. · Apr 1994
CONTAIN-OR
K934215 · Dlp, Inc. · Feb 1994
ARTHROBOT BI-FOLD DRAPE
K932253 · Andronic Devices, Ltd. · Feb 1994
VARIOUS UTILITY/SURGICAL DRAPE, STERILE, DISPOSABL
K920346 · Trinity Laboratories, Inc. · Mar 1993
COMPEL SURGICAL DRAPES
K923811 · Standard Textile Co., Inc. · Feb 1993
DRAPE UTILITY/SURGICAL STERILE DISPOSABLE
K920284 · Trinity Laboratories, Inc. · Oct 1992