510(k) · Cleared
ClearedAdvanced Computer Controlled Microkeratome-Accm, Model Surgical Instrument Systems (Sis)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgical Instrument Systems (Sis), Ltd. · HNO Keratome, Ac-Powered
Cleared on Feb 10, 2000 as substantially equivalent to K972808 (Chiron Vision Corp., 1997) and 1 other predicate after a 140-day review. Its family tree reaches back 2 generations to 1991. 2 later devices descend from it.
- Decided
- Feb 10, 2000
- Review
- 140 days
- Class
- Class I
- Product code
- HNO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K913697 (1991). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK913697 Automatic Corneal ShaperHansa Research & Development, Inc. · 1991
- 1 generation backK972808 Hansatome MicrokeratomeChiron Vision Corp. · 1997
- This deviceK993190 Advanced Computer Controlled Microkeratome-Accm, Model Surgical…Surgical Instrument Systems (Sis), Ltd. · 2000
- Descendant · cites it directly · 0 of its ownK053511 DA Vinci Femtosecond Surgical LaserSie Ltd Surgical Instrument Engineering · 2006
- Descendant · cites it directly · 0 of its ownK043150 Amadeus II EpikeratomeSis Ltd., Surgical Instrument Systems · 2005
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K913697 | Automatic Corneal Shaper | Hansa Research & Development, Inc. | 1991 | — |
| −1 | K972808 | Hansatome Microkeratome | Chiron Vision Corp. | 1997 | — |
| 0 (this device) | K993190 | Advanced Computer Controlled Microkeratome-Accm, Model Surgical Instrument… | Surgical Instrument Systems (Sis), Ltd. | 2000 | — |
| +1 | K053511 | DA Vinci Femtosecond Surgical Laser | Sie Ltd Surgical Instrument Engineering | 2006 | — |
| +1 | K043150 | Amadeus II Epikeratome | Sis Ltd., Surgical Instrument Systems | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 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 HNO? 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? (2)
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 |
|---|---|---|---|
| * | K972808 | Hansatome MicrokeratomeSummary page 1…evice or legally marketed device or devices to which substantial equivalence is being claimed: Company: Bausch & Lomb Surgical Device: Hansatome Microkeratome 510(k) : K972808 Date Cleared: October 24, 1997 Company: Bausch & Lomb Surgical Device: Advance Corneal Shaper - ACS 510(k) : K913697 Date Clea… | 1997 |
| * | K913697 | Automatic Corneal ShaperSummary page 1…Surgical Device: Hansatome Microkeratome 510(k) : K972808 Date Cleared: October 24, 1997 Company: Bausch & Lomb Surgical Device: Advance Corneal Shaper - ACS 510(k) : K913697 Date Cleared: November 5, 1991 Surgical Instrument Systems (SIS) Ltd. 510(k) Notification Advanced Computer Cont… | 1991 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 6.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K053511 (Sie Ltd Surgical Instrument Engineering, 2006) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K972808.
How does its category compare?
All HNO devicesHNO Keratome, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HNO
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · HNO
Too few HNO 510(k)s in any year since 2007 to give a median.
Recalls per year · HNO
4in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HNO
7in 2024
MAUDE reports naming product code HNO, 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 | — | 2 | 32 |
| 2008 | 1 | — | 2 | 31 |
| 2009 | 1 | — | 0 | 85 |
| 2010 | 0 | — | 0 | 84 |
| 2011 | 0 | — | 4 | 90 |
| 2012 | 0 | — | 0 | 100 |
| 2013 | 0 | — | 0 | 353 |
| 2014 | 0 | — | 0 | 452 |
| 2015 | 0 | — | 0 | 966 |
| 2016 | 0 | — | 0 | 1,397 |
| 2017 | 1 | — | 0 | 2,112 |
| 2018 | 1 | — | 0 | 2,265 |
| 2019 | 0 | — | 0 | 816 |
| 2020 | 0 | — | 0 | 405 |
| 2021 | 0 | — | 0 | 72 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 0 | — | 0 | 10 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The SIS, Ltd., ACCM microkeratome is a precision-manufactured instrument indicated for
lamellar resection of the cornea.
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/K993190 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993190: Advanced Computer Controlled Microkeratome-Accm, Model Surgical Instrument Systems (Sis).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993190
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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