510(k) · Cleared
ClearedRodenstock Scanning Laser Ophthalmoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rodenstock Instrument Corp. · HLI Ophthalmoscope, Ac-Powered
Cleared on Jan 24, 1989 after a 221-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 15 later devices descend from it.
- Decided
- Jan 24, 1989
- Review
- 221 days
- Class
- Class II
- Product code
- HLI
- Recalls
- None
- Predicates
- 0
15 later devices descend from it, 3 citing it directly.
- This deviceK882517 Rodenstock Scanning Laser OphthalmoscopeRodenstock Instrument Corp. · 1989
- 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 · cites it directly · 9 of its ownK042001 Panoramic 200AOptos Plc. · 2004
- Descendant · 2 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 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K983999PANORAMIC200 OpthalmoscopeOptos Plc. · 1999 · cites it directly13descendants
- K100644Optos Limited Panoramic 200CAFOptos Plc. · 2010 · 2 generations on9descendants
- K042001Panoramic 200AOptos Plc. · 2004 · cites it directly9descendants
- K060424Panoramic, Model 200MAOptos Plc. · 2006 · 2 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) | K882517 | Rodenstock Scanning Laser Ophthalmoscope | Rodenstock Instrument Corp. | 1989 | — |
| +1 | K983999 | PANORAMIC200 Opthalmoscope | Optos Plc. | 1999 | — |
| +2 | K100644 | Optos Limited Panoramic 200CAF | Optos Plc. | 2010 | — |
| +1 | K042001 | Panoramic 200A | Optos Plc. | 2004 | — |
| +2 | 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 |
|---|---|---|
| 1997 | 1 | 0 |
| 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), 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (15)
See all 153 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?
- 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 | — |
https://510kreport.com/device/K882517 · printed Nov 6, 2026
Cite this page
510(k) Report. “K882517: Rodenstock Scanning Laser Ophthalmoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K882517
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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