Cleared Traditional

K792726 - LEUKOFIX POROS

K792726 is an FDA 510(k) clearance for LEUKOFIX POROS, manufactured by Beiersdorf, Inc.. The device is a Class 1 General & Plastic Surgery device with product code FPX cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K792726 · Beiersdorf, Inc. · General & Plastic Surgery device
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Feb 1980
Decision
59d
Days
Class 1
Risk

K792726 is an FDA 510(k) clearance for the LEUKOFIX POROS. Classified as Strip, Adhesive, Closure, Skin (product code FPX), Class I - General Controls.

Submitted by Beiersdorf, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 28, 1980 after a review of 59 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5240 - the FDA general and plastic surgery 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 Beiersdorf, Inc. devices

FDA 510(k) Submission Details - K792726

510(k) Number K792726 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 1979
Decision Date February 28, 1980
Days to Decision 59 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 115d · This submission: 59d
Pathway characteristics
Predicate-based equivalence.

FPX Device Classification - Class 1, General Controls

Product Code FPX Strip, Adhesive, Closure, Skin
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5240
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 - FPX Strip, Adhesive, Closure, Skin

All 19
Devices cleared under the same product code (FPX) and FDA review panel - the closest regulatory comparables to K792726.
CENTRAL VENOUS CATHETER DRESSING TRAY
K802384 · American Medical Disposable, Inc. · Nov 1980
CUSTOM DRESSING TRAY-WET TO DRY/MASS.
K802385 · American Medical Disposable, Inc. · Nov 1980
FIXOMULL
K792725 · Beiersdorf, Inc. · Mar 1980
HYPO-ALLERGENIC PLASTIC TAPE
K792136 · National Patent Development Corp. · Jan 1980
LEUKOCLIP POROS
K792667 · Beiersdorf, Inc. · Jan 1980
HANSAPOR STERILE
K792360 · Beiersdorf, Inc. · Dec 1979