510(k) · Cleared
ClearedOct-Opthalmoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ophthalmic Technologies, Inc. · HLI Ophthalmoscope, Ac-Powered
Cleared on Jan 21, 2005 as substantially equivalent to K943956 (Heidelberg Engineering, 1994) after a 94-day review. Its family tree reaches back 1 generation to 1994. 5 later devices descend from it.
- Decided
- Jan 21, 2005
- Review
- 94 days
- Class
- Class II
- Product code
- HLI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K943956 (1994). 5 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK943956 Retina Tomograph and FlowmeterHeidelberg Engineering · 1994
- This deviceK042885 Oct-OpthalmoscopeOphthalmic Technologies, Inc. · 2005
- Descendant · cites it directly · 4 of its ownK080460 Spectral Oct/SloOpko Health, Inc. · 2008
- Descendant · 2 generations on · 3 of its ownK173707 P200TEOptos Plc. · 2018
- Descendant · 3 generations on · 1 of its ownK231673 P200TE (A10700)Optos Plc. · 2023
- Descendant · 4 generations on · 0 of its ownK233602 P200TE (A10700)Optos Plc. · 2024
- Descendant · 3 generations on · 0 of its ownK190732 P200TxEOptos Plc. · 2019
Most influential descendants
Showing 5 of 5 · See all- K080460Spectral Oct/SloOpko Health, Inc. · 2008 · cites it directly4descendants
- K173707P200TEOptos Plc. · 2018 · 2 generations on3descendants
- K231673P200TE (A10700)Optos Plc. · 2023 · 3 generations on1descendant
- K233602P200TE (A10700)Optos Plc. · 2024 · 4 generations on0descendants
- K190732P200TxEOptos Plc. · 2019 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K943956 | Retina Tomograph and Flowmeter | Heidelberg Engineering | 1994 | — |
| 0 (this device) | K042885 | Oct-Opthalmoscope | Ophthalmic Technologies, Inc. | 2005 | — |
| +1 | K080460 | Spectral Oct/Slo | Opko Health, Inc. | 2008 | — |
| +2 | K173707 | P200TE | Optos Plc. | 2018 | — |
| +3 | K231673 | P200TE (A10700) | Optos Plc. | 2023 | — |
| +4 | K233602 | P200TE (A10700) | Optos Plc. | 2024 | — |
| +3 | K190732 | P200TxE | Optos Plc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K012727 | FDA’s K012727 is Humphrey OCT3 Our OCR of the scanned summary read K012727, FDA’s number for Humphrey OCT3 (Carl Zeiss Ophthalmic Systems, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Optical Coherence Tomography Model 3000”. Kept off the family tree. | 2002 |
| * | K943956 | Retina Tomograph and FlowmeterSummary page 1…tion name: Ophthalmoscope, a-c powered, 8q0¶-I Id' (3) Equivalent legally-marketed devices. KOl 2727, Optical Coherence Tomography Model 3000, Zeiss Ophthalmic Systems K943956, Retina Tomnograph and Flowmeter, Heidelberg Engineering (4) Description The OTI OCT Ophthalmoscope produces simultaneo… | 1994 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080460 | Spectral Oct/Slo | 2008 | 4 |
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?
- Its one ancestor has no recall.
- Of its descendants, K080460 (Opko Health, Inc., 2008) has gone furthest, with 4 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 | — |
What is it indicated for?
The OTI OCT Ophthalmoscope is intended to offer simultaneous acquisition of high-resolution transversal OCT (Optical Coherence Tomography) and confocal images of the eye fundus. It is indicated in situations where these images are required for diagnosis.
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/K042885 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042885: Oct-Opthalmoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042885
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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