510(k) · Cleared
ClearedClarus (700)
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 Apr 17, 2025 as substantially equivalent to K191194 (Carl Zeiss Meditec, Inc., 2019) after a 120-day review. Its family tree reaches back 6 generations to 1995.
- Decided
- Apr 17, 2025
- Review
- 120 days
- Class
- Class II
- Product code
- QER
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K941234 (1995). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK941234 Non-Mydriatic Retinal CameraCanon USA, Inc. · 1995
- 5 generations backK980246 Non-Mydriatic Retinal Camera, Model CR6-45NMCanon USA, Inc. · 1998
- 4 generations backK043222 Viscucam C Digital CameraCarl Zeiss Meditec, AG · 2005
- 3 generations backK052268 Visucam Pro NMCarl Zeiss Meditec, AG · 2005
- 2 generations backK181444 ClarusCarl Zeiss Meditec, Inc. · 2019
- 1 generation backK191194 ClarusCarl Zeiss Meditec, Inc. · 2019
- This deviceK243878 Clarus (700)Carl Zeiss Meditec, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K941234 | Non-Mydriatic Retinal Camera | Canon USA, Inc. | 1995 | — |
| −5 | K980246 | Non-Mydriatic Retinal Camera, Model CR6-45NM | Canon USA, Inc. | 1998 | — |
| −4 | K043222 | Viscucam C Digital Camera | Carl Zeiss Meditec, AG | 2005 | — |
| −3 | K052268 | Visucam Pro NM | Carl Zeiss Meditec, AG | 2005 | — |
| −2 | K181444 | Clarus | Carl Zeiss Meditec, Inc. | 2019 | — |
| −1 | K191194 | Clarus | Carl Zeiss Meditec, Inc. | 2019 | — |
| 0 (this device) | 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 |
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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K191194 | ClarusSummary page 6…s: Class II Product Code: QER 3. PREDICATE DEVICE Predicate Device: CLARUS 700 v 1.1 510(k) Number: K191194 Classification: 21 CFR 886.1120 Ophthalmic Camera Regulatory Class: Class II Product Code:… | 2019 |
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 30 years and passes through 3 companies; a new generation was cleared every 5.8 years on median.
- None of the 8 ancestors has a recall.
How does its category compare?
All QER devicesQER Camera, Ophthalmic, Slit-Scanning: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K243878 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243878: Clarus (700).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243878
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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