510(k) · Cleared
ClearedUNI II
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 Oct 18, 1993 after a 339-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 6 later devices descend from it.
- Decided
- Oct 18, 1993
- Review
- 339 days
- Class
- Class II
- Product code
- HLJ
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK925756 UNI IIRudolf 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
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · 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) | K925756 | UNI II | 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 |
|---|---|---|
| 2006 | 1 | 0 |
| 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? (6)
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?
- 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/K925756 · printed Nov 6, 2026
Cite this page
510(k) Report. “K925756: UNI II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K925756
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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