510(k) · Cleared
ClearedPentacam® Cornea OCT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oculus Optikgeräte GmbH · MXK Device, Analysis, Anterior Segment
Cleared on Mar 13, 2026 as substantially equivalent to K222166 (Optovue, Inc., 2022) after a 270-day review. Its family tree reaches back 10 generations to 2002.
- Decided
- Mar 13, 2026
- Review
- 270 days
- Class
- Class II
- Product code
- MXK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K012727 (2002). 37 ancestors in all, the oldest K810880 (1981). No later device cites it as a predicate yet.
- Root · 10 generations backK012727 Humphrey OCT3Carl Zeiss Ophthalmic Systems, Inc. · 2002
- 6 generations between
- 3 generations backK153080 RTVue XR OCT Avanti with AngioVue SoftwareOptovue, Inc. · 2016
- 2 generations backK180660 AvantiOptovue, Inc. · 2018
- 1 generation backK222166 SOLIXOptovue, Inc. · 2022
- This deviceK251848 Pentacam® Cornea OCTOculus Optikgeräte GmbH · 2026
Show all 10 generations
- Root · 10 generations backK012727 Humphrey OCT3Carl Zeiss Ophthalmic Systems, Inc. · 2002
- 9 generations backK030433 Stratusoct with RNFL Normative DatabaseCarl Zeiss Meditec, Inc. · 2003 · Recalled
- 8 generations backK033123 Stratusoct with RNFL & Macula Normative DatabaseCarl Zeiss Meditec, Inc. · 2004 · Recalled
- 7 generations backK063343 Bioptigen Spectral Domain Ophthalmic Imaging SystemBioptigen, Inc. · 2006
- 6 generations backK071250 CA, Model: CamOptovue, Inc. · 2007
- 5 generations backK101505 Rtvue Model Rtvue 100Optovue, Inc. · 2010 · Recalled
- 4 generations backK120238 Rtvue XR OctOptovue, Inc. · 2012
- 3 generations backK153080 RTVue XR OCT Avanti with AngioVue SoftwareOptovue, Inc. · 2016
- 2 generations backK180660 AvantiOptovue, Inc. · 2018
- 1 generation backK222166 SOLIXOptovue, Inc. · 2022
- This deviceK251848 Pentacam® Cornea OCTOculus Optikgeräte GmbH · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K012727 | Humphrey OCT3 | Carl Zeiss Ophthalmic Systems, Inc. | 2002 | — |
| −9 | K030433 | Stratusoct with RNFL Normative Database | Carl Zeiss Meditec, Inc. | 2003 | 1 |
| −8 | K033123 | Stratusoct with RNFL & Macula Normative Database | Carl Zeiss Meditec, Inc. | 2004 | 1 |
| −7 | K063343 | Bioptigen Spectral Domain Ophthalmic Imaging System | Bioptigen, Inc. | 2006 | — |
| −6 | K071250 | CA, Model: Cam | Optovue, Inc. | 2007 | — |
| −5 | K101505 | Rtvue Model Rtvue 100 | Optovue, Inc. | 2010 | 1 |
| −4 | K120238 | Rtvue XR Oct | Optovue, Inc. | 2012 | — |
| −3 | K153080 | RTVue XR OCT Avanti with AngioVue Software | Optovue, Inc. | 2016 | — |
| −2 | K180660 | Avanti | Optovue, Inc. | 2018 | — |
| −1 | K222166 | SOLIX | Optovue, Inc. | 2022 | — |
| 0 (this device) | K251848 | Pentacam® Cornea OCT | Oculus Optikgeräte GmbH | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 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 K252348 Tomey Optical Biometer OA-2000 (OA-2000)score 11.7 · 5 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 |
|---|---|---|---|
| * | K222166 | SOLIXSummary page 5…ber: 21 C.F.R. § 886.1570 Device class: II Product Code: OBO, MXK Predicate Devices Primary Predicate: Optovue, Inc., SOLIX (K222166) Reference Device: OCULUS Optikgeräte GmbH, Pentacam® AXL Wave (K201724) Pentacam® Cornea OCT… | 2022 |
| † | K201724 | Pentacam AXL Wave | 2020 |
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 24 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
- 6 of the 37 ancestors have a recall of any class.
How does its category compare?
All MXK devicesMXK Device, Analysis, Anterior Segment: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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® Cornea OCT is a multifunction ophthalmic imaging device designed to acquire images of the anterior segment using Scheimpflug imaging (digital CMOS camera with slit-lamp illumination) and OCT.
Scheimpflug imaging provides anterior segment visualization and quantitative anterior segment measurements.
The OCT component of the system uses broadband Multi-SLD and is intended for the in vivo imaging, cross-sectional, and the three-dimensional imaging and measurement of corneal epithelium.
The Penatcam® Cornea OCT is indicated for use as a diagnostic device to aid in the detection and management of ocular diseases affecting the anterior segment of the eye.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251848 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251848: Pentacam® Cornea OCT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251848
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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