510(k) · Cleared
ClearedKeeler Tearscope-Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Keeler Instruments, Inc. · HJO Biomicroscope, Slit-Lamp, Ac-Powered
Cleared on Apr 7, 1998 after a 232-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 30 later devices descend from it.
- Decided
- Apr 7, 1998
- Review
- 232 days
- Class
- Class II
- Product code
- HJO
- Recalls
- None
- Predicates
- 0
30 later devices descend from it, 2 citing it directly.
- This deviceK973064 Keeler Tearscope-PlusKeeler Instruments, Inc. · 1998
- Descendant · cites it directly · 22 of its ownK092374 Ois Eyescan Portable Modular Imaging System, Model Ois EyescanOphthalmic Imaging Systems · 2009
- Descendant · 2 generations on · 21 of its ownK101935 Centervue Digital Retinography SystemCentervue S.P.A. · 2010
- Descendant · 3 generations on · 8 of its ownK142047 EIDONCentervue S.P.A. · 2014
- Descendant · 3 generations on · 8 of its ownK122572 Icam Fundus CameraOptovue, Inc. · 2013
- Descendant · cites it directly · 6 of its ownK091935 Lipiview Ocular Surface InterferometerTearscience, Inc. · 2009
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K092374Ois Eyescan Portable Modular Imaging System, Model Ois EyescanOphthalmic Imaging Systems · 2009 · cites it directly22descendants
- K101935Centervue Digital Retinography SystemCentervue S.P.A. · 2010 · 2 generations on21descendants
- K142047EIDONCentervue S.P.A. · 2014 · 3 generations on8descendants
- K122572Icam Fundus CameraOptovue, Inc. · 2013 · 3 generations on8descendants
- K091935Lipiview Ocular Surface InterferometerTearscience, Inc. · 2009 · cites it directly6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973064 | Keeler Tearscope-Plus | Keeler Instruments, Inc. | 1998 | — |
| +1 | K092374 | Ois Eyescan Portable Modular Imaging System, Model Ois Eyescan | Ophthalmic Imaging Systems | 2009 | — |
| +2 | K101935 | Centervue Digital Retinography System | Centervue S.P.A. | 2010 | — |
| +3 | K142047 | EIDON | Centervue S.P.A. | 2014 | — |
| +3 | K122572 | Icam Fundus Camera | Optovue, Inc. | 2013 | — |
| +1 | K091935 | Lipiview Ocular Surface Interferometer | Tearscience, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 4 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HJO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HJO device
- #1 K253834 Visuref 600score 13.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (30)
See all 302 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, K092374 (Ophthalmic Imaging Systems, 2009) has gone furthest, with 22 descendants of its own.
How does its category compare?
All HJO devicesHJO Biomicroscope, Slit-Lamp, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HJO
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HJO
232in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HJO
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HJO
20in 2025
MAUDE reports naming product code HJO, 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 | 1 |
| 2008 | 4 | 117 | 0 | 3 |
| 2009 | 3 | 91 | 0 | 3 |
| 2010 | 5 | 121 | 0 | 2 |
| 2011 | 2 | — | 0 | 5 |
| 2012 | 0 | — | 0 | 7 |
| 2013 | 2 | — | 2 | 16 |
| 2014 | 10 | 196 | 0 | 4 |
| 2015 | 2 | — | 2 | 8 |
| 2016 | 5 | 243 | 0 | 15 |
| 2017 | 9 | 232 | 0 | 15 |
| 2018 | 2 | — | 1 | 11 |
| 2019 | 0 | — | 0 | 13 |
| 2020 | 1 | — | 0 | 19 |
| 2021 | 0 | — | 0 | 14 |
| 2022 | 1 | — | 0 | 6 |
| 2023 | 0 | — | 0 | 18 |
| 2024 | 1 | — | 0 | 18 |
| 2025 | 0 | — | 0 | 20 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Specular Observation of the tear film
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973064 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973064: Keeler Tearscope-Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973064
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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