510(k) · Cleared
ClearedParkone
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 11, 2008 as substantially equivalent to K041841 (Oculus Optikgerate GmbH, 2005) after a 273-day review. Its family tree reaches back 4 generations to 1990. 1 later device descends from it.
- Decided
- Sep 11, 2008
- Review
- 273 days
- Class
- Class II
- Product code
- MXK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K902798 (1990). 14 ancestors in all, the oldest K851210 (1985). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK902798 Automated Hydrosonics (TM)Alcon Surgical, Inc. · 1990
- 3 generations backK980292 Cataract Liquefracture DeviceAlcon Laboratories · 1998
- 2 generations backK030179 Medisiss Phacoemulsification Tips/NeedlesSurgical Instruments Service and Savings, Inc. · 2003 · Recalled
- 1 generation backK041841 PachycamOculus Optikgerate GmbH · 2005
- This deviceK073508 ParkoneOculus Optikgerate GmbH · 2008
- Descendant · cites it directly · 0 of its ownK202989 Myopia MasterOculus Optikgeräte GmbH · 2021 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K202989Myopia MasterOculus Optikgeräte GmbH · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K902798 | Automated Hydrosonics (TM) | Alcon Surgical, Inc. | 1990 | — |
| −3 | K980292 | Cataract Liquefracture Device | Alcon Laboratories | 1998 | — |
| −2 | K030179 | Medisiss Phacoemulsification Tips/Needles | Surgical Instruments Service and Savings, Inc. | 2003 | 1 |
| −1 | K041841 | Pachycam | Oculus Optikgerate GmbH | 2005 | — |
| 0 (this device) | K073508 | Parkone | Oculus Optikgerate GmbH | 2008 | — |
| +1 | K202989 | Myopia Master | Oculus Optikgeräte GmbH | 2021 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 4 | 0 |
| 1993 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K041841 | PachycamSummary page 1…Devices The PARK 1 is claimed to be substantially equivalent to the following currently market device: Pachycam, Scheimpflug Camera, OCULUS Optikgeraete GmbH, Germany; K 041841 Auto-Ref-Keratometer, CANON Inc.; exempted (21CFR886.1760) DeviceDescription: The PARK 1 is a non-invasive, diagnostic system c… | 2005 |
| * | — | Auto-Ref-Keratometer Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202989 | Myopia Master | 2021 | 0 |
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 18 years and passes through 4 companies; a new generation was cleared every 4.7 years on median.
- 2 of the 14 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 K041841.
How does its category compare?
All MXK devicesMXK Device, Analysis, Anterior Segment: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 PARK 1 is designed to photograph the eye and take Scheimpflug images of the anterior segment to evaluate the thickness of the cornea. The implanted keratometer measures the central radii of the cornea. The implanted Ophthalmic Refractometer measures the refractive power of the eye.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073508 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073508: Parkone.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073508
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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