Cleared Traditional

K922845 - BASIC DRESSING CHANGE TRAY SMP 102A (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K922845 · Specialty Medical Products Co. · General Hospital
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Dec 1992
Decision
200d
Days
Class 2
Risk

K922845 is an FDA 510(k) clearance for the BASIC DRESSING CHANGE TRAY SMP 102A. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Specialty Medical Products Co. (Little Rock, US). The FDA issued a Cleared decision on December 29, 1992 after a review of 200 days - an extended review 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: 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 Specialty Medical Products Co. devices

Submission Details

510(k) Number K922845 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received June 12, 1992
Decision Date December 29, 1992
Days to Decision 200 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
72d slower than avg
Panel avg: 128d · This submission: 200d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 319
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K922845.
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