510(k) Report

510(k) · Cleared

Cleared

Silon (TM) Transparent Wound Dressing

K912032510(k) TraditionalCleared Aug 20, 1991104-day reviewClass U

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

Bio Med Sciences, Inc. · MGP Dressing, Wound And Burn, Occlusive

Cleared on Aug 20, 1991 after a 104-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it.

Decided
Aug 20, 1991
Review
104 days
Class
Class U
Product code
MGP
Recalls
None
Predicates
0

2 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1998: 1 descendant cleared1999: 1 descendant cleared1990200020102020
  1. This deviceK912032 Silon (TM) Transparent Wound DressingBio Med Sciences, Inc. · 1991
  2. Descendant · cites it directly · 0 of its ownK990042 Silon Dual-DressBio Med Sciences, Inc. · 1999
  3. Descendant · cites it directly · 0 of its ownK981665 Silon Topomat Corneal Topography Image Enhancement DeviceBio-Medical Sciences, Inc. · 1998

Most influential descendants

Showing 2 of 2 · See all
  • K990042Silon Dual-DressBio Med Sciences, Inc. · 1999 · cites it directly0descendants
  • K981665Silon Topomat Corneal Topography Image Enhancement DeviceBio-Medical Sciences, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K912032Silon (TM) Transparent Wound DressingBio Med Sciences, Inc.1991—
+1K990042Silon Dual-DressBio Med Sciences, Inc.1999—
+1K981665Silon Topomat Corneal Topography Image Enhancement DeviceBio-Medical Sciences, Inc.1998—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
199910
FIG. 1 — Lineage of K912032, 1991–1999Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MGP? 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K990042Silon Dual-DressBio Med Sciences, Inc.19990
K981665Silon Topomat Corneal Topography Image Enhancement DeviceBio-Medical Sciences, Inc.19980

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?

  • Of its descendants, K990042 (Bio Med Sciences, Inc., 1999) has gone furthest, with 0 descendants of its own.

How does its category compare?

All MGP devices

MGP Dressing, Wound And Burn, Occlusive: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MGP

FDA has decided no MGP device since 2007.

Median 510(k) review, days · MGP

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

Recalls per year · MGP

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

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

Adverse event reports per year · MGP

8in 2024

2007: 12009: 12010: 22011: 42013: 72014: 12015: 32016: 12017: 62021: 522022: 32023: 32024: 8
2007high 52 (2021) · low 0 (2008)2025

MAUDE reports naming product code MGP, 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—01
20080—00
20090—01
20100—02
20110—14
20120—00
20130—07
20140—01
20150—03
20160—01
20170—06
20180—00
20190—00
20200—00
20210—052
20220—03
20230—03
20240—08
20250—00
20260—0—

More from Bio Med Sciences, Inc.

10 FDA decisions under this applicant name. See the company

  • K023136Oleeva FabricBio Med Sciences, Inc. · 2002
  • K002109Oleeva FoamBio Med Sciences, Inc. · 2000
  • K990042Silon Dual-DressBio Med Sciences, Inc. · 1999
  • K982036Silon Scar StripsBio Med Sciences, Inc. · 1998
  • K952546Silon Silicone Textile CompositeBio Med Sciences, Inc. · 1995

Recent decisions in MGP

The MGP category page

  • K012997Collatek FoamBiocore Medical Technologies, Inc. · 2001
  • K012995Collatek SheetBiocore Medical Technologies, Inc. · 2001
  • K001508Laserskin DressingFidia Advanced Biopolymers Srl · 2001
  • K990079Fastseal Chest Wound DressingGreenfield Medical Technologies, Inc. · 1999
  • K991214Simplicare Transparent Wound DressingHollister, Inc. · 1999

https://510kreport.com/device/K912032 · printed Nov 6, 2026

Cite this page

510(k) Report. “K912032: Silon (TM) Transparent Wound Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K912032

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026