510(k) · Cleared
ClearedPropper Insight Binocular Indirect Ophthalmosope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Propper Manufacturing Co., Inc. · HLI Ophthalmoscope, Ac-Powered
Cleared on Sep 17, 2014 as substantially equivalent to K123316 (Heine Optotechnik GmbH & Co. KG, 2013) after a 90-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Sep 17, 2014
- Review
- 90 days
- Class
- Class II
- Product code
- HLI
- 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 deviceK141638 Propper Insight Binocular Indirect OphthalmosopePropper Manufacturing Co., Inc. · 2014
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) | K141638 | Propper Insight Binocular Indirect Ophthalmosope | Propper Manufacturing Co., Inc. | 2014 | — |
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 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? (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…ing principles to the following device: Predicate device 510k number Heine OMEGA 500 binocular Indirect K123316 ophthalmoscope, LED version Substantial equivalence to the predicate device was evaluated according to the FDA g… | 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 20 years and passes through 3 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 HLI devicesHLI Ophthalmoscope, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
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 | — |
What is it indicated for?
Propper InsightTM Binocular Indirect Ophthalmoscope is an AC-adapter powered or rechargeable battery powered 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/K141638 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141638: Propper Insight Binocular Indirect Ophthalmosope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141638
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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