Cleared Traditional

K800248 - SURGITEK FOERSTER FACE LIFT BANDAGE

K800248 is an FDA 510(k) clearance for SURGITEK FOERSTER FACE LIFT BANDAGE, manufactured by Medical Engineering Corp.. The device is a Class 1 General Hospital device with product code FRL cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K800248 · Medical Engineering Corp. · General Hospital
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Feb 1980
Decision
13d
Days
Class 1
Risk

K800248 is an FDA 510(k) clearance for the SURGITEK FOERSTER FACE LIFT BANDAGE. Classified as Fiber, Medical, Absorbent (product code FRL), Class I - General Controls.

Submitted by Medical Engineering Corp. (Mchenry, US). The FDA issued a Cleared decision on February 19, 1980 after a review of 13 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 Medical Engineering Corp. devices

FDA 510(k) Submission Details - K800248

510(k) Number K800248 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1980
Decision Date February 19, 1980
Days to Decision 13 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
116d faster than avg
Panel avg: 129d · This submission: 13d
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 K800248.
ICAN COTTON RAYON BALLS
K914081 · Icn Pharmaceuticals, Inc. · Oct 1991
TRACH CLEANING TRAY
K811990 · Associated Medical Products Co. · Jul 1981
UTENSIL & PROCEDURE TRAYS
K810242 · American Hospital Supply Corp. · Apr 1981
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