510(k) · Cleared
ClearedHeine Sigma 250 & Heine Sigma 250 M2
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 Jan 29, 2015 as substantially equivalent to K123316 (Heine Optotechnik GmbH & Co. KG, 2013) after a 121-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Jan 29, 2015
- Review
- 121 days
- Class
- Class II
- Product code
- HLJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K942104 (1994). 5 ancestors in all, the oldest K930023 (1993). No later device cites it as a predicate yet.
- Root · 3 generations backK942104 Keeler Vantage Indirect OphthalmoscopeKeeler Instruments, Inc. · 1994
- 2 generations backK060822 Vantage Indirect OphthalmoscopeKeeler Instruments, Inc. · 2006
- 1 generation backK123316 Heine Omega 500Heine Optotechnik GmbH & Co. KG · 2013
- This deviceK142837 Heine Sigma 250 & Heine Sigma 250 M2Heine Optotechnik GmbH & Co. KG · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K942104 | Keeler Vantage Indirect Ophthalmoscope | Keeler Instruments, Inc. | 1994 | — |
| −2 | K060822 | Vantage Indirect Ophthalmoscope | Keeler Instruments, Inc. | 2006 | — |
| −1 | K123316 | Heine Omega 500 | Heine Optotechnik GmbH & Co. KG | 2013 | — |
| 0 (this device) | K142837 | Heine Sigma 250 & Heine Sigma 250 M2 | Heine Optotechnik GmbH & Co. KG | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 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 |
|---|---|---|---|
| * | K123316 | Heine Omega 500Summary page 5…of the eye. Predicate Device: Device Trade Name: HEINE OMEGA® 500 Applicant: HEINE Optotechnik GmbH & Co. KG 510(k) No.: K123316 The indirect ophthalmoscopes HEINE SIGMA® 250 (M2) are considered substantial equivalent to the HEINE OMEGA® 500 Ophthalmoscope… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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 21 years and passes through 2 companies; a new generation was cleared every 6.8 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K123316.
How does its category compare?
All HLJ devicesHLJ Ophthalmoscope, Battery-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 SIGMA® 250 (M2) are battery powered indirect ophthalmoscopes 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/K142837 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142837: Heine Sigma 250 & Heine Sigma 250 M2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142837
Report an extraction error
Are you the manufacturer?
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