Cleared Traditional

K852203 - KIMGUARD PROCEDURE TRAY

K852203 is an FDA 510(k) clearance for KIMGUARD PROCEDURE TRAY, manufactured by Kimberly-Clark Corp.. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K852203 · Kimberly-Clark Corp. · General Hospital
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Jun 1985
Decision
17d
Days
Class 2
Risk

K852203 is an FDA 510(k) clearance for the KIMGUARD PROCEDURE TRAY. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Kimberly-Clark Corp. (Roswell, US). The FDA issued a Cleared decision on June 7, 1985 after a review of 17 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 Kimberly-Clark Corp. devices

FDA 510(k) Submission Details - K852203

510(k) Number K852203 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 1985
Decision Date June 07, 1985
Days to Decision 17 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 129d · This submission: 17d
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 141
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K852203.
DRESSING CHANG & WOUND MANAGEMENT
K920480 · Cypress Medical Products, Ltd. · Oct 1992
DRESSING CHANGE TRAY DECUBITUS ULCER/STERILE-DISP
K921490 · Trinity Laboratories, Inc. · Oct 1992
KIMGUARD (REGULAR & HEAVY DUTY) STERILE WRAP
K881471 · Kimberly-Clark Corp. · Aug 1988
ABCO INSTRUMENT PACKS & TRAYS
K851315 · Abco Dealers, Inc. · May 1985
BLUE SEAL II STERILIZATION POUCH
K851340 · American Sterilizer Co. · Apr 1985
TPN/HYPERALIMENTATION TRAY
K842644 · Deroyal Industries, Inc. · Nov 1984