Cleared Traditional

K942000 - BURN DRESSING TRAY

K942000 is an FDA 510(k) clearance for BURN DRESSING TRAY, manufactured by Medcare Custom Packaging, Inc.. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K942000 · Medcare Custom Packaging, Inc. · General Hospital
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May 1994
Decision
25d
Days
Class 2
Risk

K942000 is an FDA 510(k) clearance for the BURN DRESSING TRAY. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Medcare Custom Packaging, Inc. (E Swanzey, US). The FDA issued a Cleared decision on May 20, 1994 after a review of 25 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medcare Custom Packaging, Inc. devices

FDA 510(k) Submission Details - K942000

510(k) Number K942000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received April 25, 1994
Decision Date May 20, 1994
Days to Decision 25 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
104d faster than avg
Panel avg: 129d · This submission: 25d
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 125
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K942000.
G.E. STERILE PUNCTURE TRAY
K960202 · GE Medical Systems · Feb 1996
STERIMED STERIZATION WRAPPER (NON-STERILE)
K953678 · Customed, Inc. · Oct 1995
MAMMOCORE BIOPSY TRAY
K943653 · Manan Medical Products, Inc. · Jan 1995
ARGYLE TURKEL SAFETY PARACENTESIS PROCEDURE TRAY
K935238 · Sherwood Medical Co. · Feb 1994
CONVERTORS STERILIZATION WRAP
K921243 · Baxter Healthcare Corp · Oct 1992
DRESSING CHANGE TRAY DECUBITUS ULCER/STERILE-DISP
K921490 · Trinity Laboratories, Inc. · Oct 1992