510(k) · Cleared
ClearedP200TE
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Optos Plc. · OBO Tomography, Optical Coherence
Cleared on Feb 28, 2018 as substantially equivalent to K080460 (Opko Health, Inc., 2008) and 1 other predicate after an 86-day review. Its family tree reaches back 6 generations to 1987. 3 later devices descend from it.
- Decided
- Feb 28, 2018
- Review
- 86 days
- Class
- Class II
- Product code
- OBO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K871268 (1987). 17 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK871268 Rodenstock Scanning Laser OphthalmoscopeG. Rodenstock Instrumente GmbH · 1987
- 5 generations backK983999 PANORAMIC200 OpthalmoscopeOptos Plc. · 1999
- 4 generations backK042001 Panoramic 200AOptos Plc. · 2004
- 3 generations backK060424 Panoramic, Model 200MAOptos Plc. · 2006
- 2 generations backK102492 P200MAAFOptos Plc. · 2010
- 1 generation backK142897 P200DTxOptos Plc. · 2015
- This deviceK173707 P200TEOptos Plc. · 2018
- Descendant · cites it directly · 1 of its ownK231673 P200TE (A10700)Optos Plc. · 2023
- Descendant · 2 generations on · 0 of its ownK233602 P200TE (A10700)Optos Plc. · 2024
- Descendant · cites it directly · 0 of its ownK190732 P200TxEOptos Plc. · 2019
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K871268 | Rodenstock Scanning Laser Ophthalmoscope | G. Rodenstock Instrumente GmbH | 1987 | — |
| −5 | K983999 | PANORAMIC200 Opthalmoscope | Optos Plc. | 1999 | — |
| −4 | K042001 | Panoramic 200A | Optos Plc. | 2004 | — |
| −3 | K060424 | Panoramic, Model 200MA | Optos Plc. | 2006 | — |
| −2 | K102492 | P200MAAF | Optos Plc. | 2010 | — |
| −1 | K142897 | P200DTx | Optos Plc. | 2015 | — |
| 0 (this device) | K173707 | P200TE | Optos Plc. | 2018 | — |
| +1 | K231673 | P200TE (A10700) | Optos Plc. | 2023 | — |
| +2 | K233602 | P200TE (A10700) | Optos Plc. | 2024 | — |
| +1 | K190732 | P200TxE | Optos Plc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 OBO? 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 OBO device
- #1 K250868 SPECTRALIS HRA+OCT and variantsscore 16.2 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K080460 | Spectral Oct/SloSummary page 4…Class II A/C Powered Ophthalmoscope PRODUCT CODE: CLASSIFICATION / CFR TITLE OBO, HLI / 21 CFR 886.1570 PREDICATE DEVICES Primary Predicate: Optos Spectral OCT/SLO (K080460) Secondary Predicate: Optos P200DTx (K142897) INDICATIONS FOR USE The P200TE is a non-contact scanning laser ophthalmoscope and… | 2008 |
| * | K142897 | P200DTxSummary page 4…T CODE: CLASSIFICATION / CFR TITLE OBO, HLI / 21 CFR 886.1570 PREDICATE DEVICES Primary Predicate: Optos Spectral OCT/SLO (K080460) Secondary Predicate: Optos P200DTx (K142897) INDICATIONS FOR USE The P200TE is a non-contact scanning laser ophthalmoscope and optical coherence tomographer intended for in… | 2015 |
What descends from it? (3)
2 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 31 years and passes through 2 companies; a new generation was cleared every 4.5 years on median.
- 2 of the 17 ancestors have a recall of any class.
- Of its descendants, K231673 (Optos Plc., 2023) has gone furthest, with 1 descendant of its own.
How does its category compare?
All OBO devicesOBO Tomography, Optical Coherence: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · OBO
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OBO
125in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OBO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OBO
4in 2025
MAUDE reports naming product code OBO, 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 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 4 | 151 | 0 | 0 |
| 2010 | 2 | — | 1 | 0 |
| 2011 | 2 | — | 2 | 0 |
| 2012 | 3 | 269 | 2 | 0 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 3 | 152 | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 4 | 125 | 0 | 1 |
| 2017 | 4 | 118 | 0 | 0 |
| 2018 | 6 | 87 | 1 | 1 |
| 2019 | 5 | 249 | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 1 | 1 |
| 2022 | 2 | — | 1 | 0 |
| 2023 | 7 | 262 | 0 | 3 |
| 2024 | 8 | 157 | 0 | 3 |
| 2025 | 3 | 125 | 0 | 4 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The P200TE is a non-contact scanning laser ophthalmoscope and optical coherence tomographer intended for in-vivo viewing and digital imaging of posterior ocular structures, including the retina, retinal nerve fiber layer and optic disc. It is indicated for producing high-resolution, widefield, en face reflectance images, autofluorescence images, and axial, cross-sectional images of the posterior ocular structures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173707 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173707: P200TE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173707
Report an extraction error
Are you the manufacturer?
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