Cleared Traditional

K842115 - SPUNGARD & SURG. DRAPES-GOWNS & PACKS

K842115 is an FDA 510(k) clearance for SPUNGARD & SURG. DRAPES-GOWNS & PACKS, manufactured by Kimberly-Clark Corp.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K842115 · Kimberly-Clark Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1984
Decision
47d
Days
Class 2
Risk

K842115 is an FDA 510(k) clearance for the SPUNGARD & SURG. DRAPES-GOWNS & PACKS. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Kimberly-Clark Corp. (Walker, US). The FDA issued a Cleared decision on June 11, 1984 after a review of 47 days - a notably fast clearance cycle.

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: 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 Kimberly-Clark Corp. devices

FDA 510(k) Submission Details - K842115

510(k) Number K842115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1984
Decision Date June 11, 1984
Days to Decision 47 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 129d · This submission: 47d
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 174
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K842115.
SURGICAL DRAPES
K844802 · Procter & Gamble Mfg. Co. · Jan 1985
DRAPE SURGICAL UTILITY DRAPE STERILE
K843496 · Busse Hospital Disposables, Inc. · Oct 1984
ACU-DERM TRANSPARENT INCISE DRAPE
K841735 · Acme United Corp. · Aug 1984
SINGLE-USE SURGICAL DRAPES
K833877 · Procter & Gamble Mfg. Co. · Jan 1984
LIGHT HANDLE COVER
K832278 · Concept, Inc. · Sep 1983
GORE-TEX BARRIER SURG. DRAPES & GOWNS
K822641 · W.L. Gore & Associates, Inc. · Jan 1983