510(k) · Cleared
ClearedTomey Optical Biometer OA-2000 (OA-2000)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tomey Corporation · MXK Device, Analysis, Anterior Segment
Cleared on Dec 18, 2025 as substantially equivalent to K082891 (Haag-Streit AG, 2009) after a 142-day review. Its family tree reaches back 5 generations to 1996.
- Decided
- Dec 18, 2025
- Review
- 142 days
- Class
- Class II
- Product code
- MXK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K955442 (1996). 19 ancestors in all, the oldest K781994 (1979). No later device cites it as a predicate yet.
- Root · 5 generations backK955442 Kowa SC-1200 Photo Slit Lamp SystemKowa Optimed, Inc. · 1996
- 4 generations backK991284 Anterior Eye-Segment Analysis SystemNidek, Inc. · 1999
- 3 generations backK012873 Documenting Laser Slit Lamp, DP 2010Bausch & Lomb, Inc. · 2001
- 2 generations backK030393 Optical Low Coherence Reflectometry (Olcr) PachymeterHaag-Streit Holding AG · 2003
- 1 generation backK082891 Lenstar, Model LS900Haag-Streit AG · 2009 · Recalled
- This deviceK252348 Tomey Optical Biometer OA-2000 (OA-2000)Tomey Corporation · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K955442 | Kowa SC-1200 Photo Slit Lamp System | Kowa Optimed, Inc. | 1996 | — |
| −4 | K991284 | Anterior Eye-Segment Analysis System | Nidek, Inc. | 1999 | — |
| −3 | K012873 | Documenting Laser Slit Lamp, DP 2010 | Bausch & Lomb, Inc. | 2001 | — |
| −2 | K030393 | Optical Low Coherence Reflectometry (Olcr) Pachymeter | Haag-Streit Holding AG | 2003 | — |
| −1 | K082891 | Lenstar, Model LS900 | Haag-Streit AG | 2009 | 3 |
| 0 (this device) | K252348 | Tomey Optical Biometer OA-2000 (OA-2000) | Tomey Corporation | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 2 | 0 |
| 1990 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 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 MXK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MXK device
- #1 K251848 Pentacam® Cornea OCTscore 13.7 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K082891 | Lenstar, Model LS900Summary page 5…) The OA-2000 is substantially equivalent to the following legally marketed device: 510(k) Number Trade name Product code K082891 LenStar LS900 HJO… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 29 years and passes through 6 companies; a new generation was cleared every 3.6 years on median.
- 2 of the 19 ancestors have a recall of any class.
- 4 other devices also cite its predicate K082891.
How does its category compare?
All MXK devicesMXK Device, Analysis, Anterior Segment: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · MXK
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MXK
Too few MXK 510(k)s in any year since 2007 to give a median.
Recalls per year · MXK
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MXK
1in 2025
MAUDE reports naming product code MXK, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 1 | 2 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 2 | — | 0 | 2 |
| 2020 | 1 | — | 0 | 2 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The OA-2000 is a non-invasive, non-contact biometer intended for obtaining ocular measurements to assist in the determination of the appropriate power of an intraocular lens for implantation. The OA-2000 measures: Axial length, corneal thickness, anterior chamber depth and lens thickness.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K252348 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252348: Tomey Optical Biometer OA-2000 (OA-2000).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252348
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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