Cleared Traditional

K040936 - PETIT SILMA ELASTIC BANDAGE WITH GERMANIUM/TITANIUM OXIDE

K040936 is an FDA 510(k) clearance for PETIT SILMA ELASTIC BANDAGE WITH GERMAN..., manufactured by Leda Co., Ltd.. The device is a Class 1 General Hospital device with product code FQM cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K040936 · Leda Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2004
Decision
24d
Days
Class 1
Risk

K040936 is an FDA 510(k) clearance for the PETIT SILMA ELASTIC BANDAGE WITH GERMANIUM/TITANIUM OXIDE. Classified as Bandage, Elastic (product code FQM), Class I - General Controls.

Submitted by Leda Co., Ltd. (Washington, US). The FDA issued a Cleared decision on May 3, 2004 after a review of 24 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5075 - 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 Leda Co., Ltd. devices

FDA 510(k) Submission Details - K040936

510(k) Number K040936 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2004
Decision Date May 03, 2004
Days to Decision 24 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 129d · This submission: 24d
Pathway characteristics
Predicate-based equivalence.

FQM Device Classification - Class 1, General Controls

Product Code FQM Bandage, Elastic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5075
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 - FQM Bandage, Elastic

All 21
Devices cleared under the same product code (FQM) and FDA review panel - the closest regulatory comparables to K040936.
ASPEN ESMARK BANDAGE
K872868 · Aspen Laboratories, Inc. · Jul 1987
COMPRESSOGRIP TUBULAR ELASTIC BANDAGE
K831551 · Fred Sammons, Inc. · Jun 1983
BIAS STOCKINETTE
K820141 · Stan-Pak Ent. · Feb 1982
TUBULAR STOCKINETTE
K820142 · Stan-Pak Ent. · Feb 1982
ELASTIC BANDAGE
K820094 · Stan-Pak Ent. · Jan 1982
SOF-BAND HIGH STRETCH BANDAGES
K810137 · Johnson & Johnson Professionals, Inc. · Feb 1981