510(k) · Cleared
ClearedRetina Tomograph and Flowmeter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heidelberg Engineering · HLI Ophthalmoscope, Ac-Powered
Cleared on Nov 14, 1994 after a 91-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 6 later devices descend from it.
- Decided
- Nov 14, 1994
- Review
- 91 days
- Class
- Class II
- Product code
- HLI
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK943956 Retina Tomograph and FlowmeterHeidelberg Engineering · 1994
- Descendant · cites it directly · 5 of its ownK042885 Oct-OpthalmoscopeOphthalmic Technologies, Inc. · 2005
- Descendant · 2 generations on · 4 of its ownK080460 Spectral Oct/SloOpko Health, Inc. · 2008
- Descendant · 3 generations on · 3 of its ownK173707 P200TEOptos Plc. · 2018
- Descendant · 4 generations on · 1 of its ownK231673 P200TE (A10700)Optos Plc. · 2023
- Descendant · 5 generations on · 0 of its ownK233602 P200TE (A10700)Optos Plc. · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K042885Oct-OpthalmoscopeOphthalmic Technologies, Inc. · 2005 · cites it directly5descendants
- K080460Spectral Oct/SloOpko Health, Inc. · 2008 · 2 generations on4descendants
- K173707P200TEOptos Plc. · 2018 · 3 generations on3descendants
- K231673P200TE (A10700)Optos Plc. · 2023 · 4 generations on1descendant
- K233602P200TE (A10700)Optos Plc. · 2024 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K943956 | Retina Tomograph and Flowmeter | Heidelberg Engineering | 1994 | — |
| +1 | K042885 | Oct-Opthalmoscope | Ophthalmic Technologies, Inc. | 2005 | — |
| +2 | K080460 | Spectral Oct/Slo | Opko Health, Inc. | 2008 | — |
| +3 | K173707 | P200TE | Optos Plc. | 2018 | — |
| +4 | K231673 | P200TE (A10700) | Optos Plc. | 2023 | — |
| +5 | K233602 | P200TE (A10700) | Optos Plc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HLI? 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042885 | Oct-Opthalmoscope | 2005 | 5 |
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?
- Of its descendants, K042885 (Ophthalmic Technologies, Inc., 2005) has gone furthest, with 5 descendants of its own.
How does its category compare?
All HLI devicesHLI Ophthalmoscope, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HLI
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · HLI
112in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HLI
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HLI
2in 2024
MAUDE reports naming product code HLI, 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 | 0 | — | 1 | 1 |
| 2009 | 0 | — | 1 | 1 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 3 | 36 | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 1 |
| 2014 | 4 | 112 | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 2 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 1 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K943956 · printed Nov 6, 2026
Cite this page
510(k) Report. “K943956: Retina Tomograph and Flowmeter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K943956
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026