510(k) · Cleared
ClearedOphthalmic Knife W/Removale Depth Guide
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Myocure, Inc. · HNN Knife, Ophthalmic
Cleared on Nov 4, 1985 after a 69-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 31 later devices descend from it.
- Decided
- Nov 4, 1985
- Review
- 69 days
- Class
- Class I
- Product code
- HNN
- Recalls
- None
- Predicates
- 0
31 later devices descend from it, 1 citing it directly.
- This deviceK853598 Ophthalmic Knife W/Removale Depth GuideMyocure, Inc. · 1985
- Descendant · cites it directly · 30 of its ownK101626 Lensx Laser SystemLensx Lasers, Inc. · 2010
- Descendant · 2 generations on · 19 of its ownK113151 Ifs Laser SystemAbbott Medical Optics, Inc. · 2012
- Descendant · 2 generations on · 12 of its ownK120732 Lenssx Laser SystemAlcon Lensx, Inc. · 2012 · Recalled
- Descendant · 3 generations on · 8 of its ownK141476 Wavelight FS200 Laser SystemAlcon Research, Ltd. Dba Alcon Laboratories, Inc. · 2014
- Descendant · 3 generations on · 7 of its ownK120426 Victus Laser PlatformTechnolas Perfect Vision GmbH · 2012
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K101626Lensx Laser SystemLensx Lasers, Inc. · 2010 · cites it directly30descendants
- K113151Ifs Laser SystemAbbott Medical Optics, Inc. · 2012 · 2 generations on19descendants
- K120732Lenssx Laser SystemAlcon Lensx, Inc. · 2012 · 2 generations on12descendants
- K141476Wavelight FS200 Laser SystemAlcon Research, Ltd. Dba Alcon Laboratories, Inc. · 2014 · 3 generations on8descendants
- K120426Victus Laser PlatformTechnolas Perfect Vision GmbH · 2012 · 3 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K853598 | Ophthalmic Knife W/Removale Depth Guide | Myocure, Inc. | 1985 | — |
| +1 | K101626 | Lensx Laser System | Lensx Lasers, Inc. | 2010 | — |
| +2 | K113151 | Ifs Laser System | Abbott Medical Optics, Inc. | 2012 | — |
| +2 | K120732 | Lenssx Laser System | Alcon Lensx, Inc. | 2012 | 1 |
| +3 | K141476 | Wavelight FS200 Laser System | Alcon Research, Ltd. Dba Alcon Laboratories, Inc. | 2014 | — |
| +3 | K120426 | Victus Laser Platform | Technolas Perfect Vision GmbH | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 5 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 5 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 5 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 0 |
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 HNN? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (31)
See all 311 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101626 | Lensx Laser System | 2010 | 30 |
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, K101626 (Lensx Lasers, Inc., 2010) has gone furthest, with 30 descendants of its own.
How does its category compare?
All HNN devicesHNN Knife, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HNN
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · HNN
Too few HNN 510(k)s in any year since 2007 to give a median.
Recalls per year · HNN
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HNN
690in 2025
MAUDE reports naming product code HNN, 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 | — | 36 | 21 |
| 2008 | 0 | — | 0 | 10 |
| 2009 | 0 | — | 0 | 13 |
| 2010 | 0 | — | 1 | 149 |
| 2011 | 1 | — | 0 | 223 |
| 2012 | 0 | — | 0 | 112 |
| 2013 | 0 | — | 0 | 173 |
| 2014 | 0 | — | 0 | 169 |
| 2015 | 0 | — | 0 | 401 |
| 2016 | 0 | — | 0 | 435 |
| 2017 | 0 | — | 44 | 472 |
| 2018 | 0 | — | 0 | 420 |
| 2019 | 0 | — | 0 | 291 |
| 2020 | 0 | — | 0 | 493 |
| 2021 | 0 | — | 1 | 403 |
| 2022 | 0 | — | 1 | 327 |
| 2023 | 0 | — | 2 | 355 |
| 2024 | 0 | — | 0 | 1,844 |
| 2025 | 0 | — | 1 | 690 |
| 2026 | 0 | — | 1 | — |
https://510kreport.com/device/K853598 · printed Nov 4, 2026
Cite this page
510(k) Report. “K853598: Ophthalmic Knife W/Removale Depth Guide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K853598
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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