Cleared Traditional

K944881 - SKIN SCRUB TRAY

K944881 is an FDA 510(k) clearance for SKIN SCRUB TRAY, manufactured by Clinical Resources, Inc.. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K944881 · Clinical Resources, Inc. · General Hospital
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Dec 1994
Decision
85d
Days
Class 2
Risk

K944881 is an FDA 510(k) clearance for the SKIN SCRUB TRAY. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Clinical Resources, Inc. (Elgin, US). The FDA issued a Cleared decision on December 27, 1994 after a review of 85 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 Clinical Resources, Inc. devices

FDA 510(k) Submission Details - K944881

510(k) Number K944881 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received October 03, 1994
Decision Date December 27, 1994
Days to Decision 85 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
44d faster than avg
Panel avg: 129d · This submission: 85d
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 239
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K944881.
STERIMED STERIZATION WRAPPER (NON-STERILE)
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BIOPSY TRAY
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K935238 · Sherwood Medical Co. · Feb 1994