Cleared Traditional

K864388 - MODIFIED DISPOSABLE STERILE TOWEL USED IN SURGERY

K864388 is an FDA 510(k) clearance for MODIFIED DISPOSABLE STERILE TOWEL USED ..., manufactured by Deroyal Industries, Inc.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K864388 · Deroyal Industries, Inc. · General Hospital
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Feb 1987
Decision
106d
Days
Class 2
Risk

K864388 is an FDA 510(k) clearance for the MODIFIED DISPOSABLE STERILE TOWEL USED IN SURGERY. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Deroyal Industries, Inc. (Powell, US). The FDA issued a Cleared decision on February 20, 1987 after a review of 106 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Deroyal Industries, Inc. devices

FDA 510(k) Submission Details - K864388

510(k) Number K864388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1986
Decision Date February 20, 1987
Days to Decision 106 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
23d faster than avg
Panel avg: 129d · This submission: 106d
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 268
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K864388.
LASER RESISTANT DRAPE
K873141 · Baxter Healthcare Corp · Oct 1987
OPSITE SPECIALITY DRAPES
K872757 · Smith & Nephew, Inc. · Jul 1987
DISPOSABLE LASER PROTECTIVE DRAPE FOR CO2 LASER
K871068 · Lifestream Int'L, Inc. · May 1987
SPUNGUARD PLUS SURGICAL DRAPE
K862801 · Kimberly-Clark Corp. · Aug 1986
STERILE TOWEL W/ANTIMICROBIAL AGENT
K861969 · Deroyal Industries, Inc. · Jun 1986
STERILE STOCKINETTE W/ANTIMICROBIAL AGENT
K861196 · Deroyal Industries, Inc. · Apr 1986