Cleared Traditional

K921203 - INCISSION & DRAINAGE TRAY

K921203 is an FDA 510(k) clearance for INCISSION & DRAINAGE TRAY, manufactured by Trinity Laboratories, Inc.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K921203 · Trinity Laboratories, Inc. · General Hospital
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Aug 1992
Decision
154d
Days
Class 2
Risk

K921203 is an FDA 510(k) clearance for the INCISSION & DRAINAGE TRAY. 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

FDA 510(k) Submission Details - K921203

510(k) Number K921203 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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 129d · This submission: 154d
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 199
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K921203.
DRAPE UTILITY/SURGICAL STERILE DISPOSABLE
K920284 · Trinity Laboratories, Inc. · Oct 1992
ULCER WOUND TRAY
K922828 · Ulti-Med Intl., Inc. · Sep 1992
E.R. SUTURE TRAY, STERILE, DISPOSABLE
K920518 · Trinity Laboratories, Inc. · Aug 1992
DELUXE WOUND CLOSURE TRAY, STERILE, DISPOSABLE
K921204 · Trinity Laboratories, Inc. · Aug 1992
DRESSING CHANGE TRAY, STERILE, DISPOSABLE
K921394 · Trinity Laboratories, Inc. · Aug 1992
QUALTEX TUBE/CORD ORGANIZER
K921350 · Deroyal Industries, Inc. · Aug 1992