510(k) · Cleared
Recalled · 2003BD-3000 Microkeratome System, Model K-3000 Microkeratome
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton, Dickinson & CO · HMY Keratome, Battery-Powered
Cleared on Oct 16, 2002 as substantially equivalent to K984537 (Insight Technologies Instruments, LLC, 1999) after a 69-day review. Its family tree reaches back 1 generation to 1999. 2 later devices descend from it. It has been recalled once.
- Decided
- Oct 16, 2002
- Review
- 69 days
- Class
- Class I
- Product code
- HMY
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K984537 (1999). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK984537 Keratome System, Model K3000Insight Technologies Instruments, LLC · 1999
- This deviceK022637 BD-3000 Microkeratome System, Model K-3000 MicrokeratomeBecton, Dickinson & CO · 2002
- 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 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K984537 | Keratome System, Model K3000 | Insight Technologies Instruments, LLC | 1999 | — |
| 0 (this device) | K022637 | BD-3000 Microkeratome System, Model K-3000 Microkeratome | Becton, Dickinson & CO | 2002 | — |
| +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 | 1 | 0 |
| 2008 | 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 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? (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 |
|---|---|---|---|
| * | K984537 | Keratome System, Model K3000Summary page 3…Predicate Device K-Number 1 Clearance D a t e Insight Technologies BD K-3000TM K 984537 May 14,1999 Inc. Technology rights Microkera t o m e a c q u i r e d by B D… | 1999 |
| * | — | Microkeratome Blade with Holder for ITI Keratome System Named without a submission number |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023092 | BD K-4000 Microkeratome System | 2002 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 24, 2003 | Not classified | Z-0634-03 | Other | Microkeratome Blade may cause irregular corneal flap which may delay patients procedure. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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 BD K-3000TM Microkeratome System is a battery powered device intended to produce a corneal resection for refractive laser applications and procedures in Ophthalmic surgery, such as in Laser In-situ Keratomileusis (LASIK) surgery. The corneal resection is consistently of a predetermined diameter, thickness and uniform surface quality for precise lamellar cuts and consistent flap generation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022637 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022637: BD-3000 Microkeratome System, Model K-3000 Microkeratome.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022637
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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