510(k) · Cleared
ClearedS2LO
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Odyssey Optical Systems, LLC · HLI Ophthalmoscope, Ac-Powered
Cleared on Aug 5, 1998 after an 89-day review. The FDA summary names its predicate without a number. 14 later devices descend from it.
- Decided
- Aug 5, 1998
- Review
- 89 days
- Class
- Class II
- Product code
- HLI
- Recalls
- None
- Predicates
- 0
14 later devices descend from it, 1 citing it directly.
- This deviceK981640 S2LOOdyssey Optical Systems, LLC · 1998
- Descendant · cites it directly · 13 of its ownK983999 PANORAMIC200 OpthalmoscopeOptos Plc. · 1999
- Descendant · 2 generations on · 9 of its ownK100644 Optos Limited Panoramic 200CAFOptos Plc. · 2010
- Descendant · 2 generations on · 9 of its ownK042001 Panoramic 200AOptos Plc. · 2004
- Descendant · 3 generations on · 8 of its ownK060424 Panoramic, Model 200MAOptos Plc. · 2006
- Descendant · 3 generations on · 7 of its ownK102492 P200MAAFOptos Plc. · 2010
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K983999PANORAMIC200 OpthalmoscopeOptos Plc. · 1999 · cites it directly13descendants
- K100644Optos Limited Panoramic 200CAFOptos Plc. · 2010 · 2 generations on9descendants
- K042001Panoramic 200AOptos Plc. · 2004 · 2 generations on9descendants
- K060424Panoramic, Model 200MAOptos Plc. · 2006 · 3 generations on8descendants
- K102492P200MAAFOptos Plc. · 2010 · 3 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981640 | S2LO | Odyssey Optical Systems, LLC | 1998 | — |
| +1 | K983999 | PANORAMIC200 Opthalmoscope | Optos Plc. | 1999 | — |
| +2 | K100644 | Optos Limited Panoramic 200CAF | Optos Plc. | 2010 | — |
| +2 | K042001 | Panoramic 200A | Optos Plc. | 2004 | — |
| +3 | K060424 | Panoramic, Model 200MA | Optos Plc. | 2006 | — |
| +3 | K102492 | P200MAAF | Optos Plc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 2 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Rodenstock Scanning Laser Ophthalmoscope Named without a submission number | |
| * | — | Humphrey Optical Coherence Tomography Scanner Named without a submission number |
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K983999 | PANORAMIC200 Opthalmoscope | 1999 | 13 |
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, K983999 (Optos Plc., 1999) has gone furthest, with 13 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 Odyssey Optical Systems S*LO is indicated for diagnosing and monitoring diseases and disorders that manifest themselves in the posterior pole of the eye.
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/K981640 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981640: S2LO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981640
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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