Cleared Traditional

K850199 - POLY-LINED TOWEL/DRAPE LINE

K850199 is the FDA 510(k) clearance for POLY-LINED TOWEL/DRAPE LINE by Excel Health Care Products. It is a Class 2 General Hospital device (product code KKX) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K850199 · Excel Health Care Products · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1985
Decision
34d
Days
Class 2
Risk

K850199 is an FDA 510(k) clearance for the POLY-LINED TOWEL/DRAPE LINE. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Excel Health Care Products (S. Plainfield, US). The FDA issued a Cleared decision on February 21, 1985 after a review of 34 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 Excel Health Care Products devices

Submission Details

510(k) Number K850199 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1985
Decision Date February 21, 1985
Days to Decision 34 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 129d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 65
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K850199.
STERILE STOCKINETTE W/ANTIMICROBIAL AGENT
K861196 · Deroyal Industries, Inc. · Apr 1986
TUBULAR ORTHO. STOCKINETTE W/ANTIMICROBIAL AGENT
K860326 · Deroyal Industries, Inc. · Feb 1986
ABCO DRAPES/TOWELS
K851314 · Abco Dealers, Inc. · May 1985
SURGICAL DRAPES
K844802 · Procter & Gamble Mfg. Co. · Jan 1985
SPUNGARD & SURG. DRAPES-GOWNS & PACKS
K842115 · Kimberly-Clark Corp. · Jun 1984
SINGLE-USE SURGICAL DRAPES
K833877 · Procter & Gamble Mfg. Co. · Jan 1984