Cleared Traditional

K922041 - PRIMARY SURGICAL DRESSING TRAY

K922041 is an FDA 510(k) clearance for PRIMARY SURGICAL DRESSING TRAY, manufactured by Transidyne General Corp.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K922041 · Transidyne General Corp. · General Hospital
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Nov 1992
Decision
189d
Days
Class 2
Risk

K922041 is an FDA 510(k) clearance for the PRIMARY SURGICAL DRESSING TRAY. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Transidyne General Corp. (Spartanburg, US). The FDA issued a Cleared decision on November 6, 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 880.5860 - 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 Transidyne General Corp. devices

FDA 510(k) Submission Details - K922041

510(k) Number K922041 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received May 01, 1992
Decision Date November 06, 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.

FMF Device Classification - Class 2, Special Controls

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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 - FMF Syringe, Piston

All 480
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K922041.
BECTON DICKINSON ARTERIAL BLOOD GAS KITS
K930342 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1993
BECTON DICKINSON SAFETY-LOK SYRINGE
K924072 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1992
MONOJECT SAFETY SYRINGE, 1 CC, 3CC AND 12 CC SIZES
K922522 · Sherwood Medical Co. · Nov 1992
LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER
K922190 · Advanced Surgical, Inc. · Oct 1992
VISITEC ASPIRATING SYRINGE
K923645 · Visitec Co. · Sep 1992
ENDOPATH ENDO-SURGERY PERCUTANEOUS CATHETER INTROD
K921833 · Ethicon, Inc. · Sep 1992