Cleared Traditional

K844199 - ELASTIC STYLE IMPERVIOUS ORTHOPEDIC STOCKINET

K844199 is an FDA 510(k) clearance for ELASTIC STYLE IMPERVIOUS ORTHOPEDIC STO..., manufactured by Kleen Test Products. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K844199 · Kleen Test Products · General Hospital
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Nov 1984
Decision
8d
Days
Class 2
Risk

K844199 is an FDA 510(k) clearance for the ELASTIC STYLE IMPERVIOUS ORTHOPEDIC STOCKINET. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Kleen Test Products (Milwaukee, US). The FDA issued a Cleared decision on November 7, 1984 after a review of 8 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 Kleen Test Products devices

FDA 510(k) Submission Details - K844199

510(k) Number K844199 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1984
Decision Date November 07, 1984
Days to Decision 8 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
121d faster than avg
Panel avg: 129d · This submission: 8d
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 231
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K844199.
SURGICAL DRAPES
K844802 · Procter & Gamble Mfg. Co. · Jan 1985
I.V. START KIT & OBSTETRICAL KIT
K843724 · E.M. Adams · Jan 1985
PMS DRAPE PACK
K844465 · Professional Medical Services · Dec 1984
DRAPE SURGICAL UTILITY DRAPE STERILE
K843496 · Busse Hospital Disposables, Inc. · Oct 1984
ACU-DERM TRANSPARENT INCISE DRAPE
K841735 · Acme United Corp. · Aug 1984
SPUNGARD & SURG. DRAPES-GOWNS & PACKS
K842115 · Kimberly-Clark Corp. · Jun 1984