510(k) · Cleared
ClearedKeeler Slit Lamp H-Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Keeler, Ltd. · HJO Biomicroscope, Slit-Lamp, Ac-Powered
Cleared on Jun 27, 2013 as substantially equivalent to K100202 (Haag-Streit AG, 2010) after a 27-day review. Its family tree reaches back 2 generations to 1998. 4 later devices descend from it.
- Decided
- Jun 27, 2013
- Review
- 27 days
- Class
- Class II
- Product code
- HJO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K982057 (1998). 4 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK982057 BC 900 Slit LampHaag-Streit AG · 1998
- 1 generation backK100202 Slit Lamp BO 900, BQ 900, BP900Haag-Streit AG · 2010
- This deviceK131589 Keeler Slit Lamp H-SeriesKeeler, Ltd. · 2013
- Descendant · cites it directly · 2 of its ownK140451 Keeler Slit Lamp H-Series Digital (Halogen Bulb Option), Keeler Slit…Keeler Limited · 2014
- Descendant · cites it directly · 0 of its ownK171877 SLM-1ER, SLM-2ER, SLM-3ERChongqing Kanghua Ruiming S&T Co., Ltd. · 2017
- Descendant · 2 generations on · 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 4 of 4 · See all- K140451Keeler Slit Lamp H-Series Digital (Halogen Bulb Option), Keeler Slit Lamp H-Series…Keeler Limited · 2014 · cites it directly2descendants
- K171877SLM-1ER, SLM-2ER, SLM-3ERChongqing Kanghua Ruiming S&T Co., Ltd. · 2017 · cites it directly0descendants
- K163564Slit Lamp SL-2000Nidek Co., Ltd. · 2017 · 2 generations on0descendants
- K151394Keeler Slit LampKeeler Limited · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K982057 | BC 900 Slit Lamp | Haag-Streit AG | 1998 | — |
| −1 | K100202 | Slit Lamp BO 900, BQ 900, BP900 | Haag-Streit AG | 2010 | — |
| 0 (this device) | 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 | — |
| +1 | K171877 | SLM-1ER, SLM-2ER, SLM-3ER | Chongqing Kanghua Ruiming S&T Co., Ltd. | 2017 | — |
| +2 | 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 |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 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? (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 |
|---|---|---|---|
| * | K100202 | Slit Lamp BO 900, BQ 900, BP900Summary page 1…Product Code: Regulation Number: 510K Keeler H-Series Slit Lamp Keeler Slit Lamp - H Series AC Powered Slit lamp Biomicrdscope I 86 HJO 886.1850 Slit Lamp BQ 900 K100202 Haag-Streit AG AC Powered Slit lamp Biomicroscope Il 86 HJO 886.1850 / Project 210 Issue B Page 5 of 53 K… | 2010 |
What descends from it? (4)
3 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 15 years and passes through 2 companies; a new generation was cleared every 11.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K140451 (Keeler Limited, 2014) has gone furthest, with 2 descendants of its own.
- 6 other devices also cite its predicate K100202.
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. 2013, 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 biomicroscope 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 professionals.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K131589 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131589: Keeler Slit Lamp H-Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131589
Report an extraction error
Are you the manufacturer?
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