510(k) · Cleared
ClearedKeeler Slit Lamp
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Keeler Limited · HJO Biomicroscope, Slit-Lamp, Ac-Powered
Cleared on Sep 10, 2015 as substantially equivalent to K131589 (Keeler, Ltd., 2013) and 1 other predicate after a 107-day review. Its family tree reaches back 4 generations to 1998.
- Decided
- Sep 10, 2015
- Review
- 107 days
- Class
- Class II
- Product code
- HJO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K982057 (1998). No later device cites it as a predicate yet.
- Root · 4 generations backK982057 BC 900 Slit LampHaag-Streit AG · 1998
- 3 generations backK100202 Slit Lamp BO 900, BQ 900, BP900Haag-Streit AG · 2010
- 2 generations backK131589 Keeler Slit Lamp H-SeriesKeeler, Ltd. · 2013
- 1 generation backK140451 Keeler Slit Lamp H-Series Digital (Halogen Bulb Option), Keeler Slit…Keeler Limited · 2014
- This deviceK151394 Keeler Slit LampKeeler Limited · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K982057 | BC 900 Slit Lamp | Haag-Streit AG | 1998 | — |
| −3 | K100202 | Slit Lamp BO 900, BQ 900, BP900 | Haag-Streit AG | 2010 | — |
| −2 | K131589 | Keeler Slit Lamp H-Series | Keeler, Ltd. | 2013 | — |
| −1 | K140451 | Keeler Slit Lamp H-Series Digital (Halogen Bulb Option), Keeler Slit Lamp… | Keeler Limited | 2014 | — |
| 0 (this device) | K151394 | Keeler Slit Lamp | Keeler Limited | 2015 | — |
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 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? (2)
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 |
|---|---|---|---|
| * | K131589 | Keeler Slit Lamp H-SeriesSummary page 4…Device Identification (Unmodified) Device Trade Name: Keeler Slit Lamp - H Series and Keeler Slit Lamp H-series Digital (FDA approval letters K131589 and K140451) Common Name: AC Powered Slit lamp Bio-microscope Class: II… | 2013 |
| * | K140451 | Keeler Slit Lamp H-Series Digital (Halogen Bulb Option), Keeler Slit Lamp H-Series…Summary page 4…entification (Unmodified) Device Trade Name: Keeler Slit Lamp - H Series and Keeler Slit Lamp H-series Digital (FDA approval letters K131589 and K140451) Common Name: AC Powered Slit lamp Bio-microscope Class: II Classificat… | 2014 |
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 17 years and passes through 3 companies; a new generation was cleared every 3.3 years on median.
- None of the 4 ancestors has a recall.
- 2 other devices also cite its predicate K131589.
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. 2015, this device’s year, is highlighted.
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?
The Keeler Slit Lamp Z-series and Keeler Slit Lamp Z-series Digital are AC-powered Slit lamp bio-microscopes and is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affects the structural properties of the anterior eye segment
This device is intended to be used only by suitably trained and authorized healthcare professionals
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151394 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151394: Keeler Slit Lamp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151394
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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