Cleared Traditional

K921204 - DELUXE WOUND CLOSURE TRAY, STERILE, DISPOSABLE (FDA 510(k) Clearance)

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

K921204 · Trinity Laboratories, Inc. · General Hospital
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Aug 1992
Decision
154d
Days
Class 2
Risk

K921204 is an FDA 510(k) clearance for the DELUXE WOUND CLOSURE TRAY, STERILE, DISPOSABLE. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Trinity Laboratories, Inc. (Salisbury, US). The FDA issued a Cleared decision on August 13, 1992 after a review of 154 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 Trinity Laboratories, Inc. devices

Submission Details

510(k) Number K921204 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received March 12, 1992
Decision Date August 13, 1992
Days to Decision 154 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
26d slower than avg
Panel avg: 128d · This submission: 154d
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.