Cleared Traditional

K792295 - SORBIES

K792295 is an FDA 510(k) clearance for SORBIES, manufactured by American Hospital Supply Corp.. The device is a Class 1 General Hospital device with product code FRL cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K792295 · American Hospital Supply Corp. · General Hospital
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Dec 1979
Decision
37d
Days
Class 1
Risk

K792295 is an FDA 510(k) clearance for the SORBIES. Classified as Fiber, Medical, Absorbent (product code FRL), Class I - General Controls.

Submitted by American Hospital Supply Corp. (Mchenry, US). The FDA issued a Cleared decision on December 20, 1979 after a review of 37 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5300 - 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 American Hospital Supply Corp. devices

FDA 510(k) Submission Details - K792295

510(k) Number K792295 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1979
Decision Date December 20, 1979
Days to Decision 37 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
92d faster than avg
Panel avg: 129d · This submission: 37d
Pathway characteristics
Predicate-based equivalence.

FRL Device Classification - Class 1, General Controls

Product Code FRL Fiber, Medical, Absorbent
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5300
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - FRL Fiber, Medical, Absorbent

All 10
Devices cleared under the same product code (FRL) and FDA review panel - the closest regulatory comparables to K792295.
UTENSIL & PROCEDURE TRAYS
K810242 · American Hospital Supply Corp. · Apr 1981
SURGITEK FOERSTER FACE LIFT BANDAGE
K800248 · Medical Engineering Corp. · Feb 1980
SURGITEK FOERSTER MAMMARY BANDAGE
K800249 · Medical Engineering Corp. · Feb 1980
BREAST PAD
K792294 · American Hospital Supply Corp. · Dec 1979
DEXIDE DISPOSABLE PREP PAD
K791167 · Dexide, Inc. · Aug 1979
I.V. PREP & CARE KIT
K771551 · Jelco Laboratories · Oct 1977