510(k) · Cleared
ClearedCorvis ST
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oculus Optikgerate GmbH · HKX Tonometer, Ac-Powered
Cleared on Nov 8, 2012 as substantially equivalent to K913189 (Nidek, Inc., 1991) and 1 other predicate after a 388-day review. Its family tree reaches back 4 generations to 1990.
- Decided
- Nov 8, 2012
- Review
- 388 days
- Class
- Class II
- Product code
- HKX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K902798 (1990). 15 ancestors in all, the oldest K851210 (1985). No later device cites it as a predicate yet.
- 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 deviceK113066 Corvis STOculus Optikgerate GmbH · 2012
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) | K113066 | Corvis ST | Oculus Optikgerate GmbH | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 4 | 0 |
| 1993 | 1 | 0 |
| 1998 | 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 HKX? 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 HKX device
- #1 K253039 Auto Kerato-Refracto Tonometer TRK-3 Omniascore 11.5 · 5 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K913189 | Nidek Model NT-1000Summary page 1…MXK) Classification Name 21 C.F.R. §886.1930, Tonometer (AC Powered), Analysis, Anterior Segment Predicate Devices Nidek Incorporated, Non-Contact-Tonometer NT 1000 (K91 3189) Oculus Optikgeraete GmbH, Pachycam (K041841) Intended Use!I Indications for Use The Corvis ST is intended to measure the intra… | 1991 |
| * | K041841 | PachycamSummary page 1…, Tonometer (AC Powered), Analysis, Anterior Segment Predicate Devices Nidek Incorporated, Non-Contact-Tonometer NT 1000 (K91 3189) Oculus Optikgeraete GmbH, Pachycam (K041841) Intended Use!I Indications for Use The Corvis ST is intended to measure the intra-ocular pressure of the eye in patients with… | 2005 |
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 22 years and passes through 4 companies; a new generation was cleared every 7.7 years on median.
- 2 of the 15 ancestors have a recall of any class.
- 1 other device also cites its predicate K913189.
How does its category compare?
All HKX devicesHKX Tonometer, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · HKX
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HKX
290in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HKX
No recall names HKX since 2007.
Adverse event reports per year · HKX
1in 2015
MAUDE reports naming product code HKX, 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 | 0 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 3 | 290 | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Corvis ST is intended to measure the intra-ocular pressure of the eye in patients with less than 3 diopters of corneal astigmatism. In addition, the Corvis ST is designed to photograph the eye and take Scheimpflug images of the anterior segment of the eye to evaluate the thickness of the cornea.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113066 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113066: Corvis ST.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113066
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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