510(k) · Cleared
ClearedSlit Lamp BO 900, BQ 900, BP900
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Haag-Streit AG · HJO Biomicroscope, Slit-Lamp, Ac-Powered
Cleared on Mar 19, 2010 as substantially equivalent to K982057 (Haag-Streit AG, 1998) after a 53-day review. Its family tree reaches back 1 generation to 1998. 12 later devices descend from it.
- Decided
- Mar 19, 2010
- Review
- 53 days
- Class
- Class II
- Product code
- HJO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K982057 (1998). 12 later devices descend from it, 7 citing it directly.
- Root · 1 generation backK982057 BC 900 Slit LampHaag-Streit AG · 1998
- This deviceK100202 Slit Lamp BO 900, BQ 900, BP900Haag-Streit AG · 2010
- Descendant · cites it directly · 5 of its ownK110489 Slit Lamp SL-2GTopcon Medical Systems, Inc. · 2011
- Descendant · cites it directly · 4 of its ownK131589 Keeler Slit Lamp H-SeriesKeeler, Ltd. · 2013
- Descendant · cites it directly · 2 of its ownK133667 Slit Lamp SL-D701Topcon Corp. · 2014
- 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 · 1 of its ownK152535 Z5 Slit lamp microscope, Z2 Slit lamp microscopeTakagi Seiko Co., Ltd. · 2016
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K110489Slit Lamp SL-2GTopcon Medical Systems, Inc. · 2011 · cites it directly5descendants
- K131589Keeler Slit Lamp H-SeriesKeeler, Ltd. · 2013 · cites it directly4descendants
- K133667Slit Lamp SL-D701Topcon Corp. · 2014 · cites it directly2descendants
- K140451Keeler Slit Lamp H-Series Digital (Halogen Bulb Option), Keeler Slit Lamp H-Series…Keeler Limited · 2014 · cites it directly2descendants
- K152535Z5 Slit lamp microscope, Z2 Slit lamp microscopeTakagi Seiko Co., Ltd. · 2016 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K982057 | BC 900 Slit Lamp | Haag-Streit AG | 1998 | — |
| 0 (this device) | K100202 | Slit Lamp BO 900, BQ 900, BP900 | Haag-Streit AG | 2010 | — |
| +1 | K110489 | Slit Lamp SL-2G | Topcon Medical Systems, Inc. | 2011 | — |
| +1 | K131589 | Keeler Slit Lamp H-Series | Keeler, Ltd. | 2013 | — |
| +1 | K133667 | Slit Lamp SL-D701 | Topcon Corp. | 2014 | — |
| +1 | K140451 | Keeler Slit Lamp H-Series Digital (Halogen Bulb Option), Keeler Slit Lamp… | Keeler Limited | 2014 | — |
| +1 | K152535 | Z5 Slit lamp microscope, Z2 Slit lamp microscope | Takagi Seiko Co., Ltd. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K982057 | BC 900 Slit LampSummary page 2…valence to the following device: Manufacturer: Haag-Streit AG Device name: Slit Lamp BC 900 510(k) Premarket Notification no.: K982057 Classification name: Biomicroscope, Slit-Lamp, AC-Powered CFR title: 21 CFR 886.1850 Produc… | 1998 |
What descends from it? (12)
See all 127 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110489 | Slit Lamp SL-2G | 2011 | 5 |
| K131589 | Keeler Slit Lamp H-Series | 2013 | 4 |
| K133667 | Slit Lamp SL-D701 | 2014 | 2 |
| K140451 | Keeler Slit Lamp H-Series Digital (Halogen Bulb Option), Keeler Slit Lamp H-Series… | 2014 | 2 |
| K152535 | Z5 Slit lamp microscope, Z2 Slit lamp microscope | 2016 | 1 |
| K162636 | Marco Ultra M3, Marco Ultra M4 | 2017 | 0 |
| K133062 | Discovery System | 2014 | 0 |
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?
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. 2010, 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?
An AC-powered slitlamp biomnicroscope 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 affect the structural properties of the anterior eye segment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100202 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100202: Slit Lamp BO 900, BQ 900, BP900.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100202
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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