510(k) · Cleared
Recalled · Class II · 2023Pentacam AXL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oculus Optikgerate GmbH · MXK Device, Analysis, Anterior Segment
Cleared on Jan 20, 2016 as substantially equivalent to K122418 (Carl Zeiss Meditec, AG, 2013) and 1 other predicate after a 159-day review. Its family tree reaches back 7 generations to 1996. 3 later devices descend from it. It has been recalled 3 times.
- Decided
- Jan 20, 2016
- Review
- 159 days
- Class
- Class II
- Product code
- MXK
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 7 generations to K955442 (1996). 22 ancestors in all, the oldest K781994 (1979). 3 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK955442 Kowa SC-1200 Photo Slit Lamp SystemKowa Optimed, Inc. · 1996
- 6 generations backK991284 Anterior Eye-Segment Analysis SystemNidek, Inc. · 1999
- 5 generations backK012873 Documenting Laser Slit Lamp, DP 2010Bausch & Lomb, Inc. · 2001
- 4 generations backK030393 Optical Low Coherence Reflectometry (Olcr) PachymeterHaag-Streit Holding AG · 2003
- 3 generations backK082891 Lenstar, Model LS900Haag-Streit AG · 2009 · Recalled
- 2 generations backK101182 Iolmaster 500Carl Zeiss Meditec, AG · 2010 · Recalled
- 1 generation backK122418 Iolmaster 500Carl Zeiss Meditec, AG · 2013 · Recalled
- This deviceK152311 Pentacam AXLOculus Optikgerate GmbH · 2016
- Descendant · cites it directly · 0 of its ownK202989 Myopia MasterOculus Optikgeräte GmbH · 2021 · Recalled
- Descendant · cites it directly · 0 of its ownK201724 Pentacam AXL WaveOculus Optikgerate GmbH · 2020 · Recalled
- Descendant · cites it directly · 0 of its ownK182659 Galilei G6 Lens ProfessionalSis Ag, Surgical Instrument Systems · 2019
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K955442 | Kowa SC-1200 Photo Slit Lamp System | Kowa Optimed, Inc. | 1996 | — |
| −6 | K991284 | Anterior Eye-Segment Analysis System | Nidek, Inc. | 1999 | — |
| −5 | K012873 | Documenting Laser Slit Lamp, DP 2010 | Bausch & Lomb, Inc. | 2001 | — |
| −4 | K030393 | Optical Low Coherence Reflectometry (Olcr) Pachymeter | Haag-Streit Holding AG | 2003 | — |
| −3 | K082891 | Lenstar, Model LS900 | Haag-Streit AG | 2009 | 3 |
| −2 | K101182 | Iolmaster 500 | Carl Zeiss Meditec, AG | 2010 | 4 |
| −1 | K122418 | Iolmaster 500 | Carl Zeiss Meditec, AG | 2013 | 4 |
| 0 (this device) | K152311 | Pentacam AXL | Oculus Optikgerate GmbH | 2016 | — |
| +1 | K202989 | Myopia Master | Oculus Optikgeräte GmbH | 2021 | 1 |
| +1 | K201724 | Pentacam AXL Wave | Oculus Optikgerate GmbH | 2020 | 2 |
| +1 | K182659 | Galilei G6 Lens Professional | Sis Ag, Surgical Instrument Systems | 2019 | — |
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 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 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? (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 |
|---|---|---|---|
| * | K122418 | Iolmaster 500Summary page 4…Regulation Number: 886.1850 Device class: II Product Code: MXK, HJO Predicate Devices Carl Zeiss Meditec AG, IOLMASTER 500 (K122418) OCULUS Optikgeräte GmbH, Pentacam Scheimpflug Camera (K030719) Pentacam® AXL 510(k) Summa… | 2013 |
| * | K030719 | Pentacam Scheimpflug CameraSummary page 4…II Product Code: MXK, HJO Predicate Devices Carl Zeiss Meditec AG, IOLMASTER 500 (K122418) OCULUS Optikgeräte GmbH, Pentacam Scheimpflug Camera (K030719) Pentacam® AXL 510(k) Summary Intended Use / Indications for Use The intended use of… | 2003 |
What descends from it? (3)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 8, 2023 | Class II | Z-2483-2023 | Process control | Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements. |
| Jul 8, 2022 | Class II | Z-1673-2022 | Software design | Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs |
| Nov 21, 2017 | Class II | Z-0635-2018 | Software design | The device software versions have an anomaly which may produce an erroneous marking for the quality specification value |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 7 companies; a new generation was cleared every 2.4 years on median.
- 5 of the 22 ancestors have a recall of any class.
- Of its descendants, K202989 (Oculus Optikgeräte GmbH, 2021) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K122418.
How does its category compare?
All MXK devicesMXK Device, Analysis, Anterior Segment: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Pentacam® is designed to take photos of the anterior segment of the eye which includes the cornea, pupil, anterior chamber and lens of the eye. To evaluate: corneal shape, analyze condition of the lens (opaque crystalline lens), analyze the anterior chamber angle, analyze anterior chamber depth, analyze the volume of the anterior chamber, analyze anterior or posterior cortical opacity, analyze the location of cataracts (nuclear, sub capsular and or…
Read the full statement (102 words)
The Pentacam® is designed to take photos of the anterior segment of the eye which includes the cornea, pupil, anterior chamber and lens of the eye. To evaluate:
corneal shape,
analyze condition of the lens (opaque crystalline lens),
analyze the anterior chamber angle,
analyze anterior chamber depth,
analyze the volume of the anterior chamber,
analyze anterior or posterior cortical opacity,
analyze the location of cataracts (nuclear, sub capsular and or cortical), using cross slit imaging with densitometry,
corneal thickness,
axial length,
white-to-white distance.
The Pentacam® AXL also performs calculations to assist physicians in determining the power of the intraocular lens for implantation.
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/K152311 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152311: Pentacam AXL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152311
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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