Cleared Traditional

K803294 - GUARDIAN STERILIZATION WRAP

K803294 is an FDA 510(k) clearance for GUARDIAN STERILIZATION WRAP, 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 34-day FDA review.

K803294 · Kimberly-Clark Corp. · General Hospital
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Feb 1981
Decision
34d
Days
Class 2
Risk

K803294 is an FDA 510(k) clearance for the GUARDIAN STERILIZATION WRAP. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Kimberly-Clark Corp. (Walker, US). The FDA issued a Cleared decision on February 2, 1981 after a review of 34 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 - K803294

510(k) Number K803294 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1980
Decision Date February 02, 1981
Days to Decision 34 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
95d faster than avg
Panel avg: 129d · This submission: 34d
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 K803294.
ECONOMY LINE OF TRAYS
K820589 · Abco Dealers, Inc. · Apr 1982
STERI-LOK DUAL PURPOSE PACKAGING/8400
K811670 · 3M Company · Jul 1981
ALOFT STERILIZATION WRAP
K803306 · American Hospital Supply Corp. · Feb 1981
GUARDIAN PEEL POUCHES
K803293 · Kimberly-Clark Corp. · Jan 1981
HYPERALIMENTATION SUBCLAVIIAN DRESS TRAY
K802577 · Associated Medical Products Co. · Nov 1980
PROPPER SHARPGUARD & TRAYPAD STERIL. AID
K802428 · Propper Mfg. Co., Inc. · Oct 1980