510(k) · Cleared
Recalled · 2007BD K-4000 Microkeratome System
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 18, 2002 as substantially equivalent to K984537 (Insight Technologies Instruments, LLC, 1999) and 1 other predicate after a 30-day review. Its family tree reaches back 2 generations to 1999. 1 later device descends from it. It has been recalled once.
- Decided
- Oct 18, 2002
- Review
- 30 days
- Class
- Class I
- Product code
- HMY
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K984537 (1999). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK984537 Keratome System, Model K3000Insight Technologies Instruments, LLC · 1999
- 1 generation backK022637 BD-3000 Microkeratome System, Model K-3000 MicrokeratomeBecton, Dickinson & CO · 2002 · Recalled
- This deviceK023092 BD K-4000 Microkeratome SystemBecton, Dickinson & CO · 2002
- Descendant · cites it directly · 0 of its ownK082043 Carriazo-Pendular MicrokeratomeSchwind Eye-Tech-Solutions GmbH & Co. KG · 2008
Most influential descendants
Showing 1 of 1 · See all- K082043Carriazo-Pendular MicrokeratomeSchwind Eye-Tech-Solutions GmbH & Co. KG · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 |
| 0 (this device) | K023092 | BD K-4000 Microkeratome System | Becton, Dickinson & CO | 2002 | — |
| +1 | K082043 | Carriazo-Pendular Microkeratome | Schwind Eye-Tech-Solutions GmbH & Co. KG | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 2…Manufacturer I Predicate Device K-Number Clearance Date Becton 1 BD K-3000" Microkeratome K984537 Sept. May 14,1999 Dickinson BD K-3O0Om Microkeratome… | 1999 |
| * | K022637 | BD-3000 Microkeratome System, Model K-3000 Microkeratome Cleared while this submission was under review | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082043 | Carriazo-Pendular Microkeratome | 2008 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 9, 2007 | Not classified | Z-0066-2008 | Component design/selection | Microkeratome blade may stop oscillating and transverse the eye causing injury to the cornea |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 3.4 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K082043 (Schwind Eye-Tech-Solutions GmbH & Co. KG, 2008) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K984537.
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-4000TM Microkeratome System is a battery powered device intended to produce a corneal resection for refractive laser applications and procedures in Ophthalmic surgery, such as Laser In-situ Keratomileuses (LASIK) surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023092 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023092: BD K-4000 Microkeratome System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023092
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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