Cleared Traditional

DRESSING CHANGE TRAY DECUBITUS ULCER/STERILE-DISP (K921490) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

Device Classification

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 102
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K921490.
G.E. STERILE PUNCTURE TRAY
K960202 · GE Medical Systems · Feb 1996
ARGYLE TURKEL SAFETY PARACENTESIS PROCEDURE TRAY
K935238 · Sherwood Medical Co. · Feb 1994
CONVERTORS STERILIZATION WRAP
K921243 · Baxter Healthcare Corp · Oct 1992
KIMGUARD (REGULAR & HEAVY DUTY) STERILE WRAP
K881471 · Kimberly-Clark Corp. · Aug 1988
KIMGUARD PROCEDURE TRAY
K852203 · Kimberly-Clark Corp. · Jun 1985
ABCO INSTRUMENT PACKS & TRAYS
K851315 · Abco Dealers, Inc. · May 1985