Cleared Traditional

K791167 - DEXIDE DISPOSABLE PREP PAD

K791167 is an FDA 510(k) clearance for DEXIDE DISPOSABLE PREP PAD, manufactured by Dexide, Inc.. The device is a Class 1 General Hospital device with product code FRL cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K791167 · Dexide, Inc. · General Hospital
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Aug 1979
Decision
39d
Days
Class 1
Risk

K791167 is an FDA 510(k) clearance for the DEXIDE DISPOSABLE PREP PAD. Classified as Fiber, Medical, Absorbent (product code FRL), Class I - General Controls.

Submitted by Dexide, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 3, 1979 after a review of 39 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 Dexide, Inc. devices

FDA 510(k) Submission Details - K791167

510(k) Number K791167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1979
Decision Date August 03, 1979
Days to Decision 39 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
90d faster than avg
Panel avg: 129d · This submission: 39d
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 13
Devices cleared under the same product code (FRL) and FDA review panel - the closest regulatory comparables to K791167.
SURGITEK FOERSTER MAMMARY BANDAGE
K800249 · Medical Engineering Corp. · Feb 1980
SORBIES
K792295 · American Hospital Supply Corp. · Dec 1979
BREAST PAD
K792294 · American Hospital Supply Corp. · Dec 1979
I.V. PREP & CARE KIT
K771551 · Jelco Laboratories · Oct 1977
COTTON BALL KIT
K770588 · American Hospital Supply Corp. · May 1977