Cleared Traditional

K921490 - DRESSING CHANGE TRAY DECUBITUS ULCER/ST...

K921490 is an FDA 510(k) clearance for DRESSING CHANGE TRAY DECUBITUS ULCER/ST..., manufactured by Trinity Laboratories, Inc.. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K921490 · Trinity Laboratories, Inc. · General Hospital
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Oct 1992
Decision
189d
Days
Class 2
Risk

K921490 is an FDA 510(k) clearance for the DRESSING CHANGE TRAY DECUBITUS ULCER/STERILE-DISP. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Trinity Laboratories, Inc. (Salisbury, US). The FDA issued a Cleared decision on October 5, 1992 after a review of 189 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6850 - 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 Trinity Laboratories, Inc. devices

FDA 510(k) Submission Details - K921490

510(k) Number K921490 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received March 30, 1992
Decision Date October 05, 1992
Days to Decision 189 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 129d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRG Device Classification - Class 2, Special Controls

Product Code FRG Wrap, Sterilization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6850
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 - FRG Wrap, Sterilization

All 172
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K921490.
WRAPPEL T
K923408 · Standard Textile Co., Inc. · Apr 1993
CONVERTORS STERILIZATION WRAP
K921243 · Baxter Healthcare Corp · Oct 1992
DRESSING CHANG & WOUND MANAGEMENT
K920480 · Cypress Medical Products, Ltd. · Oct 1992
KIMGUARD (REGULAR & HEAVY DUTY) STERILE WRAP
K881471 · Kimberly-Clark Corp. · Aug 1988
CENTRAL SUPPLY ROOM WRAP
K873175 · Ulti-Med Intl., Inc. · Sep 1987
KIMGUARD PROCEDURE TRAY
K852203 · Kimberly-Clark Corp. · Jun 1985