510(k) Report

510(k) · Cleared

Cleared

Petit Silma Elastic Bandage with Germanium/Titanium Oxide

K040936510(k) TraditionalCleared May 3, 200424-day reviewClass I21 CFR 880.5075

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Leda Co., Ltd. · FQM Bandage, Elastic

Cleared on May 3, 2004 as substantially equivalent to K013239 (Med Gen, Inc., 2001) after a 24-day review. Its family tree reaches back 1 generation to 2001.

Decided
May 3, 2004
Review
24 days
Class
Class I
Product code
FQM
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K013239 (2001). No later device cites it as a predicate yet.

K013239 · Comfortcare Compression Support with Magnets Comfortcare Magnetic Insoles · Med Gen, Inc. · 20012000200220042006
K013239 · Comfortcare Compression Support with Magnets Comfortcare Magnetic Insoles · Med Gen, Inc. · 20010
  1. Root · 1 generation backK013239 Comfortcare Compression Support with Magnets Comfortcare Magnetic…Med Gen, Inc. · 2001
  2. This deviceK040936 Petit Silma Elastic Bandage with Germanium/Titanium OxideLeda Co., Ltd. · 2004
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K013239Comfortcare Compression Support with Magnets Comfortcare Magnetic InsolesMed Gen, Inc.2001—
0 (this device)K040936Petit Silma Elastic Bandage with Germanium/Titanium OxideLeda Co., Ltd.2004—
FIG. 1 — Lineage of K040936, 2001–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FQM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K013239Comfortcare Compression Support with Magnets Comfortcare Magnetic Insoles
Summary page 1
…880.5075) Product Code: FQM Predicate Devices: Comfort Care T M Compression Support With Magnets, 510(k) # K013239, manufactured by Med Gen, Inc. Device Description: The Petit Silma Elastic Bandage is a simple device to…
Med Gen, Inc.2001—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.

How does its category compare?

All FQM devices

FQM Bandage, Elastic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FQM

FDA has decided no FQM device since 2007.

Median 510(k) review, days · FQM

Too few FQM 510(k)s in any year since 2007 to give a median.

Recalls per year · FQM

6in 2019

2008: 22017: 12019: 62026 (partial year): 1
2007high 6 (2019) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FQM

6in 2025

2007: 32008: 22009: 52010: 22011: 22012: 72013: 72014: 52015: 82016: 102017: 82018: 132019: 102020: 642021: 732022: 232023: 102024: 52025: 6
2007high 73 (2021) · low 2 (2008)2025

MAUDE reports naming product code FQM, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—03
20080—22
20090—05
20100—02
20110—02
20120—07
20130—07
20140—05
20150—08
20160—010
20170—18
20180—013
20190—610
20200—064
20210—073
20220—023
20230—010
20240—05
20250—06
20260—1—

What is it indicated for?

The Petit Silma Elastic Bandage with Germanium/Titanium Oxide is designed to

provide relief of minor physicial discomforts that have their origin in stress and strain of

repetitive actions associated with athletic, workplace and at-home activities. The device

provides support for unprotected vulnerable body parts and post-injury impact induced

by overexertion in self-limiting physical injuries.

Indications for use as stated in the FDA summary.

Recent decisions in FQM

The FQM category page

  • K040054Back in Action Compression & Support with Magnets for the Lower Back, Knee and AnkleTheodore Barash · 2004
  • K013244Comfortcare Compression Support Witih Magnets and Aegis Microbe Shield Comfortcare Magnetic Insoles and…Med Gen, Inc. · 2001
  • K952738Skin Saver SystemsSkin Saver Systems, Inc. · 1995
  • K872868Aspen Esmark BandageAspen Laboratories, Inc. · 1987
  • K840107Tube-Bandage for Human Digits 200Zens Health Care Products · 1984

https://510kreport.com/device/K040936 · printed Nov 5, 2026

Cite this page

510(k) Report. “K040936: Petit Silma Elastic Bandage with Germanium/Titanium Oxide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040936

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026