510(k) · Cleared
ClearedVisucam Pro NM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carl Zeiss Meditec, AG · HKI Camera, Ophthalmic, Ac-Powered
Cleared on Nov 2, 2005 as substantially equivalent to K043222 (Carl Zeiss Meditec, AG, 2005) after a 75-day review. Its family tree reaches back 3 generations to 1995. 21 later devices descend from it.
- Decided
- Nov 2, 2005
- Review
- 75 days
- Class
- Class II
- Product code
- HKI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K941234 (1995). 5 ancestors in all. 21 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK941234 Non-Mydriatic Retinal CameraCanon USA, Inc. · 1995
- 2 generations backK980246 Non-Mydriatic Retinal Camera, Model CR6-45NMCanon USA, Inc. · 1998
- 1 generation backK043222 Viscucam C Digital CameraCarl Zeiss Meditec, AG · 2005
- This deviceK052268 Visucam Pro NMCarl Zeiss Meditec, AG · 2005
- Descendant · cites it directly · 13 of its ownK112184 Cirrus PhotoCarl Zeiss Meditec, Inc. · 2012
- Descendant · 2 generations on · 5 of its ownK141844 Rescan 700, Callisto EyeCarl Zeiss Meditec, AG · 2014
- Descendant · 2 generations on · 3 of its ownK150467 Retina WorkplaceCarl Zeiss Meditec, AG · 2015
- Descendant · 2 generations on · 3 of its ownK133217 Cirrus PhotoCarl Zeiss Meditec, AG · 2014
- Descendant · cites it directly · 3 of its ownK091064 Navilas Laser SystemOd-Os GmbH · 2009
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K112184Cirrus PhotoCarl Zeiss Meditec, Inc. · 2012 · cites it directly13descendants
- K141844Rescan 700, Callisto EyeCarl Zeiss Meditec, AG · 2014 · 2 generations on5descendants
- K150467Retina WorkplaceCarl Zeiss Meditec, AG · 2015 · 2 generations on3descendants
- K133217Cirrus PhotoCarl Zeiss Meditec, AG · 2014 · 2 generations on3descendants
- K091064Navilas Laser SystemOd-Os GmbH · 2009 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K941234 | Non-Mydriatic Retinal Camera | Canon USA, Inc. | 1995 | — |
| −2 | K980246 | Non-Mydriatic Retinal Camera, Model CR6-45NM | Canon USA, Inc. | 1998 | — |
| −1 | K043222 | Viscucam C Digital Camera | Carl Zeiss Meditec, AG | 2005 | — |
| 0 (this device) | K052268 | Visucam Pro NM | Carl Zeiss Meditec, AG | 2005 | — |
| +1 | K112184 | Cirrus Photo | Carl Zeiss Meditec, Inc. | 2012 | — |
| +2 | K141844 | Rescan 700, Callisto Eye | Carl Zeiss Meditec, AG | 2014 | — |
| +2 | K150467 | Retina Workplace | Carl Zeiss Meditec, AG | 2015 | — |
| +2 | K133217 | Cirrus Photo | Carl Zeiss Meditec, AG | 2014 | — |
| +1 | K091064 | Navilas Laser System | Od-Os GmbH | 2009 | — |
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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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 HKI? 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 HKI device
- #1 K253176 TearViewscore 12.8 · 5 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 |
|---|---|---|---|
| * | K043222 | Viscucam C Digital CameraSummary page 1…Regulation Name/No.: Camera, Ophthalmic, AC-powered; (21 CFR§ 886.1120) Product Code: HKI PREDICATE DEUICE VJSUCAMTM C Digital Camera (K043222) 000158… | 2005 |
What descends from it? (21)
See all 213 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)
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 10 years and passes through 2 companies; a new generation was cleared every 2.9 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K112184 (Carl Zeiss Meditec, Inc., 2012) has gone furthest, with 13 descendants of its own.
How does its category compare?
All HKI devicesHKI Camera, Ophthalmic, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HKI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HKI
167in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HKI
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HKI
1in 2023
MAUDE reports naming product code HKI, 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 | 2 | — | 0 | 3 |
| 2008 | 5 | 29 | 0 | 1 |
| 2009 | 11 | 104 | 0 | 1 |
| 2010 | 6 | 140 | 0 | 0 |
| 2011 | 7 | 160 | 0 | 0 |
| 2012 | 5 | 179 | 1 | 2 |
| 2013 | 7 | 141 | 0 | 22 |
| 2014 | 4 | 135 | 0 | 3 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 4 | 146 | 1 | 66 |
| 2017 | 2 | — | 1 | 20 |
| 2018 | 6 | 71 | 1 | 14 |
| 2019 | 4 | 73 | 0 | 0 |
| 2020 | 5 | 182 | 0 | 5 |
| 2021 | 4 | 155 | 0 | 3 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 5 | 259 | 0 | 1 |
| 2024 | 3 | 28 | 0 | 0 |
| 2025 | 4 | 167 | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The VISUCAM PRO NM Digital Camera is suitable for photographing, displaying and storing the data of the retina and surrounding parts of the eye to be examined under mydriatic and non-mydriatic conditions. These photographs support the diagnosis and subsequent observation of eye diseases which can be visually monitored and photographically documented.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052268 · printed Nov 4, 2026
Cite this page
510(k) Report. “K052268: Visucam Pro NM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K052268
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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