510(k) · Cleared
ClearedPrecision Optics Corporation Video Ophthalmoscope, Model 2500-Vos
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Precision Optics Corp. · HLJ Ophthalmoscope, Battery-Powered
Cleared on Jan 9, 2006 as substantially equivalent to K951210 (Welch Allyn, Inc., 1995) after a 32-day review. Its family tree reaches back 1 generation to 1995. 3 later devices descend from it.
- Decided
- Jan 9, 2006
- Review
- 32 days
- Class
- Class II
- Product code
- HLJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K951210 (1995). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK951210 Welch Allyn Video OphthalmoscopeWelch Allyn, Inc. · 1995
- This deviceK053425 Precision Optics Corporation Video Ophthalmoscope, Model 2500-VosPrecision Optics Corp. · 2006
- Descendant · cites it directly · 2 of its ownK102412 Vista Digital OpthalmoscopeEyequick.Llc · 2011
- Descendant · 2 generations on · 1 of its ownK121405 PanopticWelch Allyn, Inc. · 2012
- Descendant · 3 generations on · 0 of its ownK223381 iExaminer System with Panoptic PlusWelch Allyn, Inc. · 2023
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K951210 | Welch Allyn Video Ophthalmoscope | Welch Allyn, Inc. | 1995 | — |
| 0 (this device) | K053425 | Precision Optics Corporation Video Ophthalmoscope, Model 2500-Vos | Precision Optics Corp. | 2006 | — |
| +1 | K102412 | Vista Digital Opthalmoscope | Eyequick.Llc | 2011 | — |
| +2 | K121405 | Panoptic | Welch Allyn, Inc. | 2012 | — |
| +3 | K223381 | iExaminer System with Panoptic Plus | Welch Allyn, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K951210 | Welch Allyn Video OphthalmoscopeSummary page 1…II Classification Panel: Ophthalmic (Battery Powered) Predicate Device: Welch Allyn Video Ophthalmoscope (510(k) #K951210) Device Description: The Precision Optics Corporation Video Ophthalmoscope is a hand held indirect and direct monocular device f… | 1995 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102412 | Vista Digital Opthalmoscope | 2011 | 2 |
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?
- Its one ancestor has no recall.
- Of its descendants, K102412 (Eyequick.Llc, 2011) has gone furthest, with 2 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 | — |
What is it indicated for?
The Video Ophthalmoscope is intended to be used by trained personnel to examine the cornea, aqueous, lens, vitreous, and retina of the eye.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053425 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053425: Precision Optics Corporation Video Ophthalmoscope, Model 2500-Vos.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053425
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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