510(k) · Cleared
Recalled · Class II · 2022Pentacam Scheimpflug Camera
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 Sep 16, 2003 as substantially equivalent to K991284 (Nidek, Inc., 1999) after a 193-day review. Its family tree reaches back 2 generations to 1996. 18 later devices descend from it. It has been recalled once.
- Decided
- Sep 16, 2003
- Review
- 193 days
- Class
- Class II
- Product code
- MXK
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K955442 (1996). 3 ancestors in all. 18 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK955442 Kowa SC-1200 Photo Slit Lamp SystemKowa Optimed, Inc. · 1996
- 1 generation backK991284 Anterior Eye-Segment Analysis SystemNidek, Inc. · 1999
- This deviceK030719 Pentacam Scheimpflug CameraOculus Optikgerate GmbH · 2003
- Descendant · cites it directly · 8 of its ownK111505 Rtvue Cam with Corneal Power UpgradeOptovue, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 5 of its ownK180660 AvantiOptovue, Inc. · 2018
- Descendant · cites it directly · 3 of its ownK152311 Pentacam AXLOculus Optikgerate GmbH · 2016 · Recalled
- Descendant · cites it directly · 3 of its ownK143086 VX120 Ophthalmic Diagnostic DeviceLuneau Sas · 2015
- Descendant · 3 generations on · 1 of its ownK222166 SOLIXOptovue, Inc. · 2022
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K111505Rtvue Cam with Corneal Power UpgradeOptovue, Inc. · 2011 · cites it directly8descendants
- K180660AvantiOptovue, Inc. · 2018 · 2 generations on5descendants
- K152311Pentacam AXLOculus Optikgerate GmbH · 2016 · cites it directly3descendants
- K143086VX120 Ophthalmic Diagnostic DeviceLuneau Sas · 2015 · cites it directly3descendants
- K222166SOLIXOptovue, Inc. · 2022 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K955442 | Kowa SC-1200 Photo Slit Lamp System | Kowa Optimed, Inc. | 1996 | — |
| −1 | K991284 | Anterior Eye-Segment Analysis System | Nidek, Inc. | 1999 | — |
| 0 (this device) | K030719 | Pentacam Scheimpflug Camera | Oculus Optikgerate GmbH | 2003 | — |
| +1 | K111505 | Rtvue Cam with Corneal Power Upgrade | Optovue, Inc. | 2011 | 1 |
| +2 | K180660 | Avanti | Optovue, Inc. | 2018 | — |
| +1 | K152311 | Pentacam AXL | Oculus Optikgerate GmbH | 2016 | 3 |
| +1 | K143086 | VX120 Ophthalmic Diagnostic Device | Luneau Sas | 2015 | — |
| +3 | K222166 | SOLIX | Optovue, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K991284 | Anterior Eye-Segment Analysis SystemSummary page 1…he Pentacam Scheimpflug Camera is claimed to be substantially equivalent to the following currently market device: NIDEK, EAS- 1000 Anterior Eye-Segment Analysis System- K99 1284 Device Description: The Pentacam Scheimpflug Camera is a non-invasive, diagnostic system created to take photographs of the ant… | 1999 |
What descends from it? (18)
See all 185 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 |
|---|---|---|---|---|
| Jul 8, 2022 | Class II | Z-1674-2022 | 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 |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K111505 (Optovue, Inc., 2011) has gone furthest, with 8 descendants of its own.
- 1 other device also cites its predicate K991284.
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 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,
analyse condition of the lens (opaque crystalline lens),
0 analyse the anterior chamber angle,
0 analyse anterior chamber depth,
0 analyse the volume of the anterior chamber,
0 analyse anterior or posterior cortical opacity,
analyse the location of cataracts (nuclear, subcapsular and or cortical), using cross
slit imaging with densitometry,
corneal thickness.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030719 · printed Nov 5, 2026
Cite this page
510(k) Report. “K030719: Pentacam Scheimpflug Camera.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K030719
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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