510(k) · Cleared
ClearedSilon Topomat Corneal Topography Image Enhancement Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Medical Sciences, Inc. · MMQ Topographer, Corneal, Ac-Powered
Cleared on Dec 7, 1998 as substantially equivalent to K912032 (Bio Med Sciences, Inc., 1991) and 1 other predicate after a 210-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Dec 7, 1998
- Review
- 210 days
- Class
- Class I
- Product code
- MMQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K912032 (1991). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK912032 Silon (TM) Transparent Wound DressingBio Med Sciences, Inc. · 1991
- This deviceK981665 Silon Topomat Corneal Topography Image Enhancement DeviceBio-Medical Sciences, Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K912032 | Silon (TM) Transparent Wound Dressing | Bio Med Sciences, Inc. | 1991 | — |
| 0 (this device) | K981665 | Silon Topomat Corneal Topography Image Enhancement Device | Bio-Medical Sciences, Inc. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
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 MMQ? 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
What was it cleared against? (4)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K912032 | Silon (TM) Transparent Wound DressingSummary page 1…ing techniques. PRODUCT EQUIVALENCY Bio Med Sciences claims substantial equivalency for Silon Topomat to the following devices: i. Siion® Transparent Wound Dressings (K912032 & K923150) Bio Med Sciences, Inc. 101 Technology Drive Bethlehem, PA 18015 USA Silon interpenetrating polymer network of polydim… | 1991 |
| * | K923150 | Silon Transparent Wound DressingsSummary page 1…ques. PRODUCT EQUIVALENCY Bio Med Sciences claims substantial equivalency for Silon Topomat to the following devices: i. Siion® Transparent Wound Dressings (K912032 & K923150) Bio Med Sciences, Inc. 101 Technology Drive Bethlehem, PA 18015 USA Silon interpenetrating polymer network of polydimethylsilox… | 1992 |
| * | — | SilSoft® Aphakic Extended-Wear Contact Lens Named without a submission number | |
| * | — | Fluorescein Dye Named without a submission number |
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?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K912032.
How does its category compare?
All MMQ devicesMMQ Topographer, Corneal, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MMQ
FDA has decided no MMQ device since 2007.
Median 510(k) review, days · MMQ
Too few MMQ 510(k)s in any year since 2007 to give a median.
Recalls per year · MMQ
No recall names MMQ since 2007.
Adverse event reports per year · MMQ
1in 2025
MAUDE reports naming product code MMQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For the measurement of the topographical surface of the cornea using rasterstereographic imaging techniques.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981665 · printed Nov 5, 2026
Cite this page
510(k) Report. “K981665: Silon Topomat Corneal Topography Image Enhancement Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K981665
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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