510(k) · Cleared
ClearedOptical Low Coherence Reflectometry (Olcr) Pachymeter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Haag-Streit Holding AG · MXK Device, Analysis, Anterior Segment
Cleared on Sep 25, 2003 as substantially equivalent to K993357 (Carl Zeiss, Inc., 2000) and 1 other predicate after a 232-day review. Its family tree reaches back 3 generations to 1996. 16 later devices descend from it.
- Decided
- Sep 25, 2003
- Review
- 232 days
- Class
- Class II
- Product code
- MXK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K955442 (1996). 10 ancestors in all, the oldest K781994 (1979). 16 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK955442 Kowa SC-1200 Photo Slit Lamp SystemKowa Optimed, Inc. · 1996
- 2 generations backK991284 Anterior Eye-Segment Analysis SystemNidek, Inc. · 1999
- 1 generation backK012873 Documenting Laser Slit Lamp, DP 2010Bausch & Lomb, Inc. · 2001
- This deviceK030393 Optical Low Coherence Reflectometry (Olcr) PachymeterHaag-Streit Holding AG · 2003
- Descendant · cites it directly · 14 of its ownK082891 Lenstar, Model LS900Haag-Streit AG · 2009 · Recalled
- Descendant · 2 generations on · 10 of its ownK101182 Iolmaster 500Carl Zeiss Meditec, AG · 2010 · Recalled
- Descendant · 3 generations on · 9 of its ownK122418 Iolmaster 500Carl Zeiss Meditec, AG · 2013 · Recalled
- Descendant · 2 generations on · 4 of its ownK143275 IOLMaster700Carl Zeiss Meditec, Inc. · 2015
- Descendant · 3 generations on · 3 of its ownK170171 IOLMaster 700Carl Zeiss Meditec, AG · 2017 · Recalled
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K082891Lenstar, Model LS900Haag-Streit AG · 2009 · cites it directly14descendants
- K101182Iolmaster 500Carl Zeiss Meditec, AG · 2010 · 2 generations on10descendants
- K122418Iolmaster 500Carl Zeiss Meditec, AG · 2013 · 3 generations on9descendants
- K143275IOLMaster700Carl Zeiss Meditec, Inc. · 2015 · 2 generations on4descendants
- K170171IOLMaster 700Carl Zeiss Meditec, AG · 2017 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K955442 | Kowa SC-1200 Photo Slit Lamp System | Kowa Optimed, Inc. | 1996 | — |
| −2 | K991284 | Anterior Eye-Segment Analysis System | Nidek, Inc. | 1999 | — |
| −1 | K012873 | Documenting Laser Slit Lamp, DP 2010 | Bausch & Lomb, Inc. | 2001 | — |
| 0 (this device) | K030393 | Optical Low Coherence Reflectometry (Olcr) Pachymeter | Haag-Streit Holding AG | 2003 | — |
| +1 | K082891 | Lenstar, Model LS900 | Haag-Streit AG | 2009 | 3 |
| +2 | K101182 | Iolmaster 500 | Carl Zeiss Meditec, AG | 2010 | 4 |
| +3 | K122418 | Iolmaster 500 | Carl Zeiss Meditec, AG | 2013 | 4 |
| +2 | K143275 | IOLMaster700 | Carl Zeiss Meditec, Inc. | 2015 | — |
| +3 | K170171 | IOLMaster 700 | Carl Zeiss Meditec, AG | 2017 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 2 | 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? (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 |
|---|---|---|---|
| * | K993357 | IolmasterSummary page 2…depth, axial length measurements and corneal radius and thickness. The OLCR Pachymeter is, specifically, substantially equivalent to the IOLMaster from Carl Zeiss Inc. (K993357) and the Documenting Laser Slit Lamp from Bausch & Lomb Inc. (KO1 2873). The OLCR Pachymeter is substantially equivalent to the I… | 2000 |
| * | K012873 | Documenting Laser Slit Lamp, DP 2010 | 2001 |
What descends from it? (16)
See all 162 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?
- The line of descent spans 7 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K082891 (Haag-Streit AG, 2009) has gone furthest, with 14 descendants of its own.
- 2 other devices also cite its predicate K993357.
How does its category compare?
All MXK devicesMXK Device, Analysis, Anterior Segment: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 OLCR Pachymeter Pachy-01 SL is a device used with slit-lamp systems to measure corneal thickness. The OLCR Pachy-01 SL includes the functional capability to perform calculations of residual stroma thickness and correction to intraocular pressure values from user input.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030393 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030393: Optical Low Coherence Reflectometry (Olcr) Pachymeter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030393
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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