510(k) · Cleared
ClearedClarus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carl Zeiss Meditec, Inc. · QER Camera, Ophthalmic, Slit-Scanning
Cleared on Jun 25, 2019 as substantially equivalent to K181444 (Carl Zeiss Meditec, Inc., 2019) after a 53-day review. Its family tree reaches back 5 generations to 1995. 1 later device descends from it.
- Decided
- Jun 25, 2019
- Review
- 53 days
- Class
- Class II
- Product code
- QER
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K941234 (1995). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK941234 Non-Mydriatic Retinal CameraCanon USA, Inc. · 1995
- 4 generations backK980246 Non-Mydriatic Retinal Camera, Model CR6-45NMCanon USA, Inc. · 1998
- 3 generations backK043222 Viscucam C Digital CameraCarl Zeiss Meditec, AG · 2005
- 2 generations backK052268 Visucam Pro NMCarl Zeiss Meditec, AG · 2005
- 1 generation backK181444 ClarusCarl Zeiss Meditec, Inc. · 2019
- This deviceK191194 ClarusCarl Zeiss Meditec, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK243878 Clarus (700)Carl Zeiss Meditec, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K243878Clarus (700)Carl Zeiss Meditec, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K941234 | Non-Mydriatic Retinal Camera | Canon USA, Inc. | 1995 | — |
| −4 | K980246 | Non-Mydriatic Retinal Camera, Model CR6-45NM | Canon USA, Inc. | 1998 | — |
| −3 | K043222 | Viscucam C Digital Camera | Carl Zeiss Meditec, AG | 2005 | — |
| −2 | K052268 | Visucam Pro NM | Carl Zeiss Meditec, AG | 2005 | — |
| −1 | K181444 | Clarus | Carl Zeiss Meditec, Inc. | 2019 | — |
| 0 (this device) | K191194 | Clarus | Carl Zeiss Meditec, Inc. | 2019 | — |
| +1 | K243878 | Clarus (700) | Carl Zeiss Meditec, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 QER? 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 QER device
- #1 K243878 Clarus (700)score 10.7 · 6 generations · no Class I recall
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.
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 |
|---|---|---|---|
| K243878 | Clarus (700) | 2025 | 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 24 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K243878 (Carl Zeiss Meditec, Inc., 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All QER devicesQER Camera, Ophthalmic, Slit-Scanning: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · QER
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QER
Too few QER 510(k)s in any year since 2007 to give a median.
Recalls per year · QER
No recall names QER since 2007.
Adverse event reports per year · QER
No MAUDE report names QER since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The CLARUS 700 ophthalmic camera is indicated to capture, display, annotate and store images to aid in the diagnosis and monitoring of diseases and disorders occurring in the retina, ocular surface and visible adnexa. It provides true color and autofluorescence imaging modes for stereo, widefield, ultra‐widefield, and montage fields of view.
The CLARUS 700 angiography is indicated as an aid in the visualization of vascular structures of the retina and the choroid.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191194 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191194: Clarus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191194
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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