Cleared Traditional

K921049 - SURGICAL DRAPE

K921049 is an FDA 510(k) clearance for SURGICAL DRAPE, manufactured by Amsco Sterile Recoveries, Inc.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K921049 · Amsco Sterile Recoveries, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1992
Decision
210d
Days
Class 2
Risk

K921049 is an FDA 510(k) clearance for the SURGICAL DRAPE. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Amsco Sterile Recoveries, Inc. (Clearwater, US). The FDA issued a Cleared decision on October 1, 1992 after a review of 210 days - an extended review 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: 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 Amsco Sterile Recoveries, Inc. devices

FDA 510(k) Submission Details - K921049

510(k) Number K921049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1992
Decision Date October 01, 1992
Days to Decision 210 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 129d · This submission: 210d
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 165
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K921049.
CONTAIN-OR
K934215 · Dlp, Inc. · Feb 1994
VARIOUS UTILITY/SURGICAL DRAPE, STERILE, DISPOSABL
K920346 · Trinity Laboratories, Inc. · Mar 1993
DRAPE UTILITY/SURGICAL STERILE DISPOSABLE
K920284 · Trinity Laboratories, Inc. · Oct 1992
E.R. SUTURE TRAY, STERILE, DISPOSABLE
K920518 · Trinity Laboratories, Inc. · Aug 1992
INCISSION & DRAINAGE TRAY
K921203 · Trinity Laboratories, Inc. · Aug 1992
DELUXE WOUND CLOSURE TRAY, STERILE, DISPOSABLE
K921204 · Trinity Laboratories, Inc. · Aug 1992