510(k) · Cleared
ClearedKeratome System, Model K3000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Insight Technologies Instruments, LLC · HMY Keratome, Battery-Powered
Cleared on May 14, 1999 after a 144-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- May 14, 1999
- Review
- 144 days
- Class
- Class I
- Product code
- HMY
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK984537 Keratome System, Model K3000Insight Technologies Instruments, LLC · 1999
- Descendant · cites it directly · 2 of its ownK022637 BD-3000 Microkeratome System, Model K-3000 MicrokeratomeBecton, Dickinson & CO · 2002 · Recalled
- Descendant · cites it directly · 1 of its ownK023092 BD K-4000 Microkeratome SystemBecton, Dickinson & CO · 2002 · Recalled
- Descendant · 2 generations on · 0 of its ownK082043 Carriazo-Pendular MicrokeratomeSchwind Eye-Tech-Solutions GmbH & Co. KG · 2008
Most influential descendants
Showing 3 of 3 · See all- K022637BD-3000 Microkeratome System, Model K-3000 MicrokeratomeBecton, Dickinson & CO · 2002 · cites it directly2descendants
- K023092BD K-4000 Microkeratome SystemBecton, Dickinson & CO · 2002 · cites it directly1descendant
- K082043Carriazo-Pendular MicrokeratomeSchwind Eye-Tech-Solutions GmbH & Co. KG · 2008 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K984537 | Keratome System, Model K3000 | Insight Technologies Instruments, LLC | 1999 | — |
| +1 | K022637 | BD-3000 Microkeratome System, Model K-3000 Microkeratome | Becton, Dickinson & CO | 2002 | 1 |
| +1 | K023092 | BD K-4000 Microkeratome System | Becton, Dickinson & CO | 2002 | 1 |
| +2 | K082043 | Carriazo-Pendular Microkeratome | Schwind Eye-Tech-Solutions GmbH & Co. KG | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2008 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HMY? 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’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
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?
- Of its descendants, K022637 (Becton, Dickinson & CO, 2002) has gone furthest, with 2 descendants of its own.
How does its category compare?
All HMY devicesHMY Keratome, Battery-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HMY
FDA has decided no HMY device since 2007.
Median 510(k) review, days · HMY
Too few HMY 510(k)s in any year since 2007 to give a median.
Recalls per year · HMY
1in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HMY
1in 2025
MAUDE reports naming product code HMY, 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 | — | 1 | 1 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 13 |
| 2021 | 0 | — | 0 | 7 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Insight Technologies Instruments, Model K3000 Keratome System is designed to produce a corneal flap.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K984537 · printed Nov 6, 2026
Cite this page
510(k) Report. “K984537: Keratome System, Model K3000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984537
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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