510(k) · Cleared
ClearedOphthalmoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rudolf Riester GmbH & Co. KG · HLJ Ophthalmoscope, Battery-Powered
Cleared on Aug 3, 1993 after a 263-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 5 later devices descend from it.
- Decided
- Aug 3, 1993
- Review
- 263 days
- Class
- Class II
- Product code
- HLJ
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK925757 OphthalmoscopeRudolf Riester GmbH & Co. KG · 1993
- Descendant · cites it directly · 4 of its ownK070270 Piccolight E50,Piccolight E56,Eurolight E10, Eurolight E30, and…Kirchner & Wilhelm GmbH + Co.Kg · 2007
- Descendant · 2 generations on · 3 of its ownK123587 Heine Mini 3000 Led OphthalmoscopeHeine Optotechnik GmbH & Co. KG · 2013
- Descendant · 3 generations on · 0 of its ownK142486 Heine Beta 200, Heine Beta 200 S, Heine K 180Heine Optotechnik GmbH & Co. KG · 2015
- Descendant · 3 generations on · 0 of its ownK131959 Heine Mini 3000(R) OphthalmoscopeHeine Optotechnik GmbH & Co. KG · 2014
- Descendant · 3 generations on · 0 of its ownK131961 Heine Beta 200(R) OphthalmoscopeHeine Optotechnik GmbH & Co. KG · 2013
Most influential descendants
Showing 5 of 5 · See all- K070270Piccolight E50,Piccolight E56,Eurolight E10, Eurolight E30, and Eurolight E36Kirchner & Wilhelm GmbH + Co.Kg · 2007 · cites it directly4descendants
- K123587Heine Mini 3000 Led OphthalmoscopeHeine Optotechnik GmbH & Co. KG · 2013 · 2 generations on3descendants
- K142486Heine Beta 200, Heine Beta 200 S, Heine K 180Heine Optotechnik GmbH & Co. KG · 2015 · 3 generations on0descendants
- K131959Heine Mini 3000(R) OphthalmoscopeHeine Optotechnik GmbH & Co. KG · 2014 · 3 generations on0descendants
- K131961Heine Beta 200(R) OphthalmoscopeHeine Optotechnik GmbH & Co. KG · 2013 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K925757 | Ophthalmoscope | Rudolf Riester GmbH & Co. KG | 1993 | — |
| +1 | K070270 | Piccolight E50,Piccolight E56,Eurolight E10, Eurolight E30, and Eurolight E36 | Kirchner & Wilhelm GmbH + Co.Kg | 2007 | — |
| +2 | K123587 | Heine Mini 3000 Led Ophthalmoscope | Heine Optotechnik GmbH & Co. KG | 2013 | — |
| +3 | K142486 | Heine Beta 200, Heine Beta 200 S, Heine K 180 | Heine Optotechnik GmbH & Co. KG | 2015 | — |
| +3 | K131959 | Heine Mini 3000(R) Ophthalmoscope | Heine Optotechnik GmbH & Co. KG | 2014 | — |
| +3 | K131961 | Heine Beta 200(R) Ophthalmoscope | Heine Optotechnik GmbH & Co. KG | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 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 HLJ? 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
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 |
|---|---|---|---|
| K070270 | Piccolight E50,Piccolight E56,Eurolight E10, Eurolight E30, and Eurolight E36 | 2007 | 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?
- Of its descendants, K070270 (Kirchner & Wilhelm GmbH + Co.Kg, 2007) has gone furthest, with 4 descendants of its own.
How does its category compare?
All HLJ devicesHLJ Ophthalmoscope, Battery-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HLJ
2in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · HLJ
140in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HLJ
No recall names HLJ since 2007.
Adverse event reports per year · HLJ
1in 2023
MAUDE reports naming product code HLJ, 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 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 3 | 140 | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K925757 · printed Nov 3, 2026
Cite this page
510(k) Report. “K925757: Ophthalmoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K925757
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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