510(k) · Cleared
ClearedAmadeus II Epikeratome
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sis Ltd., Surgical Instrument Systems · HNO Keratome, Ac-Powered
Cleared on Jan 31, 2005 as substantially equivalent to K993190 (Surgical Instrument Systems (Sis), Ltd., 2000) after a 77-day review. Its family tree reaches back 3 generations to 1991.
- Decided
- Jan 31, 2005
- Review
- 77 days
- Class
- Class I
- Product code
- HNO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K913697 (1991). No later device cites it as a predicate yet.
- Root · 3 generations backK913697 Automatic Corneal ShaperHansa Research & Development, Inc. · 1991
- 2 generations backK972808 Hansatome MicrokeratomeChiron Vision Corp. · 1997
- 1 generation backK993190 Advanced Computer Controlled Microkeratome-Accm, Model Surgical…Surgical Instrument Systems (Sis), Ltd. · 2000
- This deviceK043150 Amadeus II EpikeratomeSis Ltd., Surgical Instrument Systems · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K913697 | Automatic Corneal Shaper | Hansa Research & Development, Inc. | 1991 | — |
| −2 | K972808 | Hansatome Microkeratome | Chiron Vision Corp. | 1997 | — |
| −1 | K993190 | Advanced Computer Controlled Microkeratome-Accm, Model Surgical Instrument… | Surgical Instrument Systems (Sis), Ltd. | 2000 | — |
| 0 (this device) | K043150 | Amadeus II Epikeratome | Sis Ltd., Surgical Instrument Systems | 2005 | — |
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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K993190 | Advanced Computer Controlled Microkeratome-Accm, Model Surgical Instrument Systems (Sis)Summary page 2…e Amadeus II Epikeratome is intended for use in performing lamellar comeal resections. This is the same intended use as previously cleared for the Amadeus microkeratome, K993190. Indications for Use The Amadeus II Epikeratome is intended for use in the separation of epithelium from the cornea in prepara… | 2000 |
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?
- The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 5.0 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K993190.
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 Amadeus II Epikeratome is intended for use in the separation of epithelium from the cornea in preparation for subsequent surgical procedures on the denuded cornea.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043150 · printed Nov 5, 2026
Cite this page
510(k) Report. “K043150: Amadeus II Epikeratome.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K043150
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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