510(k) · Cleared
ClearedP200TxE
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 Jul 31, 2019 as substantially equivalent to K173707 (Optos Plc., 2018) and 1 other predicate after a 132-day review. Its family tree reaches back 7 generations to 1987.
- Decided
- Jul 31, 2019
- Review
- 132 days
- Class
- Class II
- Product code
- OBO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K871268 (1987). 18 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK871268 Rodenstock Scanning Laser OphthalmoscopeG. Rodenstock Instrumente GmbH · 1987
- 6 generations backK983999 PANORAMIC200 OpthalmoscopeOptos Plc. · 1999
- 5 generations backK042001 Panoramic 200AOptos Plc. · 2004
- 4 generations backK060424 Panoramic, Model 200MAOptos Plc. · 2006
- 3 generations backK102492 P200MAAFOptos Plc. · 2010
- 2 generations backK142897 P200DTxOptos Plc. · 2015
- 1 generation backK173707 P200TEOptos Plc. · 2018
- This deviceK190732 P200TxEOptos Plc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K871268 | Rodenstock Scanning Laser Ophthalmoscope | G. Rodenstock Instrumente GmbH | 1987 | — |
| −6 | K983999 | PANORAMIC200 Opthalmoscope | Optos Plc. | 1999 | — |
| −5 | K042001 | Panoramic 200A | Optos Plc. | 2004 | — |
| −4 | K060424 | Panoramic, Model 200MA | Optos Plc. | 2006 | — |
| −3 | K102492 | P200MAAF | Optos Plc. | 2010 | — |
| −2 | K142897 | P200DTx | Optos Plc. | 2015 | — |
| −1 | K173707 | P200TE | Optos Plc. | 2018 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K173707 | P200TESummary page 4…moscope (21 CFR §866.1570) Regulatory Class Class II Product Code OBO/MYC Predicate Devices Primary: P200TE ‘Monaco’ (Optos Plc K173707) Secondary: P200DTx ‘California’ (Optos Plc K142897) Device Description P200TxE is a desktop re… | 2018 |
| * | K142897 | P200DTxSummary page 4…OBO/MYC Predicate Devices Primary: P200TE ‘Monaco’ (Optos Plc K173707) Secondary: P200DTx ‘California’ (Optos Plc K142897) Device Description P200TxE is a desktop retinal imaging device that can perform ultra-widefield scanning laser ophthalmosco… | 2015 |
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 32 years and passes through 2 companies; a new generation was cleared every 4.3 years on median.
- 2 of the 18 ancestors have a recall of any class.
- 1 other device also cites its predicate K173707.
How does its category compare?
All OBO devicesOBO Tomography, Optical Coherence: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 P200TxE is a non-contact scanning laser ophthalmoscope and optical coherence tomographer intended for in-vivo digital imaging of posterior ocular structures, including the vitro-retinal interface, retina, retinal layers, optic disc, choroid and choroido-scleral interface. It is indicated for producing high-resolution, wide field, en-face reflectance images, auto fluorescence images, fluorescein angiography images, indocyanine green angiography images, and axial cross-sectional images of the posterior ocular structures.
The system enables practitioners to capture multi-modal images in support of detection, investigation and monitoring of retinal conditions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190732 · printed Nov 5, 2026
Cite this page
510(k) Report. “K190732: P200TxE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K190732
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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