510(k) · Cleared
ClearedCataract Diamond Knife
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Technology Development Corp. · HNN Knife, Ophthalmic
Cleared on Oct 31, 1986 after a 38-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
- Oct 31, 1986
- Review
- 38 days
- Class
- Class I
- Product code
- HNN
- Recalls
- None
- Predicates
- 0
31 later devices descend from it, 2 citing it directly.
- This deviceK863725 Cataract Diamond KnifeMedical Technology Development Corp. · 1986
- Descendant · cites it directly · 30 of its ownK101626 Lensx Laser SystemLensx Lasers, Inc. · 2010
- Descendant · cites it directly · 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 · 2 generations on · 8 of its ownK141476 Wavelight FS200 Laser SystemAlcon Research, Ltd. Dba Alcon Laboratories, Inc. · 2014
- Descendant · 2 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 · cites it directly19descendants
- K120732Lenssx Laser SystemAlcon Lensx, Inc. · 2012 · 2 generations on12descendants
- K141476Wavelight FS200 Laser SystemAlcon Research, Ltd. Dba Alcon Laboratories, Inc. · 2014 · 2 generations on8descendants
- K120426Victus Laser PlatformTechnolas Perfect Vision GmbH · 2012 · 2 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K863725 | Cataract Diamond Knife | Medical Technology Development Corp. | 1986 | — |
| +1 | K101626 | Lensx Laser System | Lensx Lasers, Inc. | 2010 | — |
| +1 | K113151 | Ifs Laser System | Abbott Medical Optics, Inc. | 2012 | — |
| +2 | K120732 | Lenssx Laser System | Alcon Lensx, Inc. | 2012 | 1 |
| +2 | K141476 | Wavelight FS200 Laser System | Alcon Research, Ltd. Dba Alcon Laboratories, Inc. | 2014 | — |
| +2 | 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 312 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?
- 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/K863725 · printed Nov 6, 2026
Cite this page
510(k) Report. “K863725: Cataract Diamond Knife.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K863725
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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