510(k) · Cleared
ClearedKeeler Slit Lamp H-Series Digital (Halogen Bulb Option), Keeler Slit Lamp H-Series Digital (Led Option)
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 Jul 11, 2014 as substantially equivalent to K131589 (Keeler, Ltd., 2013) and 1 other predicate after a 137-day review. Its family tree reaches back 3 generations to 1998. 2 later devices descend from it.
- Decided
- Jul 11, 2014
- Review
- 137 days
- Class
- Class II
- Product code
- HJO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K982057 (1998). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK982057 BC 900 Slit LampHaag-Streit AG · 1998
- 2 generations backK100202 Slit Lamp BO 900, BQ 900, BP900Haag-Streit AG · 2010
- 1 generation backK131589 Keeler Slit Lamp H-SeriesKeeler, Ltd. · 2013
- This deviceK140451 Keeler Slit Lamp H-Series Digital (Halogen Bulb Option), Keeler Slit…Keeler Limited · 2014
- Descendant · cites it directly · 0 of its ownK163564 Slit Lamp SL-2000Nidek Co., Ltd. · 2017
- Descendant · cites it directly · 0 of its ownK151394 Keeler Slit LampKeeler Limited · 2015
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K982057 | BC 900 Slit Lamp | Haag-Streit AG | 1998 | — |
| −2 | K100202 | Slit Lamp BO 900, BQ 900, BP900 | Haag-Streit AG | 2010 | — |
| −1 | K131589 | Keeler Slit Lamp H-Series | Keeler, Ltd. | 2013 | — |
| 0 (this device) | K140451 | Keeler Slit Lamp H-Series Digital (Halogen Bulb Option), Keeler Slit Lamp… | Keeler Limited | 2014 | — |
| +1 | K163564 | Slit Lamp SL-2000 | Nidek Co., Ltd. | 2017 | — |
| +1 | K151394 | Keeler Slit Lamp | Keeler Limited | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 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 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 1…cited is the Keeler non-digital version of the same instrument: Device Trade Name: Keeler Slit Lamp H- Series 510(k) Number: K131589 Common Name: AC Powered Slit lamp Rio-microscope Class: 11 Classificati… | 2013 |
| * | K100202 | Slit Lamp BO 900, BQ 900, BP900Summary page 1…: Device Trade Name: Slit Lamp 80900 (with IM900 Imaging Module Option) Manufacturer: Haag Streit AG 510(k) Number: K100202 Common Name: AC Powered Slit lamp Rio-microscope Class: 11 Classificati… | 2010 |
What descends from it? (2)
2 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?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 3.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K163564 (Nidek Co., Ltd., 2017) has gone furthest, with 0 descendants of its own.
- 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. 2014, 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 is an AC-powered slit lamp bio-niicroscope 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 authorised healthcare pmofessionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140451 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140451: Keeler Slit Lamp H-Series Digital (Halogen Bulb Option), Keeler Slit Lamp H-Series Digital (Led Option).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140451
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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