510(k) · Cleared
ClearedHeine Mini 3000 Led Ophthalmoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heine Optotechnik GmbH & Co. KG · HLJ Ophthalmoscope, Battery-Powered
Cleared on Mar 22, 2013 as substantially equivalent to K070270 (Kirchner & Wilhelm GmbH + Co.Kg, 2007) after a 121-day review. Its family tree reaches back 2 generations to 1993. 3 later devices descend from it.
- Decided
- Mar 22, 2013
- Review
- 121 days
- Class
- Class II
- Product code
- HLJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K925757 (1993). 4 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK925757 OphthalmoscopeRudolf Riester GmbH & Co. KG · 1993
- 1 generation backK070270 Piccolight E50,Piccolight E56,Eurolight E10, Eurolight E30, and…Kirchner & Wilhelm GmbH + Co.Kg · 2007
- This deviceK123587 Heine Mini 3000 Led OphthalmoscopeHeine Optotechnik GmbH & Co. KG · 2013
- Descendant · cites it directly · 0 of its ownK142486 Heine Beta 200, Heine Beta 200 S, Heine K 180Heine Optotechnik GmbH & Co. KG · 2015
- Descendant · cites it directly · 0 of its ownK131959 Heine Mini 3000(R) OphthalmoscopeHeine Optotechnik GmbH & Co. KG · 2014
- Descendant · cites it directly · 0 of its ownK131961 Heine Beta 200(R) OphthalmoscopeHeine Optotechnik GmbH & Co. KG · 2013
Most influential descendants
Showing 3 of 3 · See all- K142486Heine Beta 200, Heine Beta 200 S, Heine K 180Heine Optotechnik GmbH & Co. KG · 2015 · cites it directly0descendants
- K131959Heine Mini 3000(R) OphthalmoscopeHeine Optotechnik GmbH & Co. KG · 2014 · cites it directly0descendants
- K131961Heine Beta 200(R) OphthalmoscopeHeine Optotechnik GmbH & Co. KG · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | K123587 | Heine Mini 3000 Led Ophthalmoscope | Heine Optotechnik GmbH & Co. KG | 2013 | — |
| +1 | K142486 | Heine Beta 200, Heine Beta 200 S, Heine K 180 | Heine Optotechnik GmbH & Co. KG | 2015 | — |
| +1 | K131959 | Heine Mini 3000(R) Ophthalmoscope | Heine Optotechnik GmbH & Co. KG | 2014 | — |
| +1 | K131961 | Heine Beta 200(R) Ophthalmoscope | Heine Optotechnik GmbH & Co. KG | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 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 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? (1)
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 |
|---|---|---|---|
| * | K070270 | Piccolight E50,Piccolight E56,Eurolight E10, Eurolight E30, and Eurolight E36Summary page 2…etina of the eye. Predicate Device: Device Trade Name: Piccolight® E50 Applicant: Kirchner & Wilhelm GmbH & CO. KG 510 (k) No.: K070270 The HEINE mini3000® LED Ophthalmoscope is considered substantial equivalent to the Piccolight® E5O Ophthalmoscope (K070270). T… | 2007 |
What descends from it? (3)
3 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?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 14.3 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K142486 (Heine Optotechnik GmbH & Co. KG, 2015) has gone furthest, with 0 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. 2013, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The HEINE mini 3000® LED Ophthalmoscope is a battery powered hand-held device for
medical professionals, containing illumination and viewing optics intended to examine the
media (cornea, aqueous, lens, vitreous) and the retina of the eye.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123587 · printed Nov 5, 2026
Cite this page
510(k) Report. “K123587: Heine Mini 3000 Led Ophthalmoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123587
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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