510(k) · Cleared
ClearedTomey EM-1000 Specular Microscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tomey Corporation USA · HJO Biomicroscope, Slit-Lamp, Ac-Powered
Cleared on Nov 22, 1994 after a 48-day review. The FDA summary names no predicate by number. 3 later devices descend from it.
- Decided
- Nov 22, 1994
- Review
- 48 days
- Class
- Class II
- Product code
- HJO
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK944910 Tomey EM-1000 Specular MicroscopeTomey Corporation USA · 1994
- Descendant · cites it directly · 2 of its ownK971953 ConfoscanTomey Corporation USA · 1997
- Descendant · 2 generations on · 1 of its ownK012416 Confoscan 2 Confocal MicroscopeNidek Technologies Srl · 2001
- Descendant · 3 generations on · 0 of its ownK042742 Heidelberg Retina Tomograph II / Rostock Cornea Module (HRT II / RCM)Heidelberg Engineering · 2004
Most influential descendants
Showing 3 of 3 · See all- K971953ConfoscanTomey Corporation USA · 1997 · cites it directly2descendants
- K012416Confoscan 2 Confocal MicroscopeNidek Technologies Srl · 2001 · 2 generations on1descendant
- K042742Heidelberg Retina Tomograph II / Rostock Cornea Module (HRT II / RCM)Heidelberg Engineering · 2004 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K944910 | Tomey EM-1000 Specular Microscope | Tomey Corporation USA | 1994 | — |
| +1 | K971953 | Confoscan | Tomey Corporation USA | 1997 | — |
| +2 | K012416 | Confoscan 2 Confocal Microscope | Nidek Technologies Srl | 2001 | — |
| +3 | K042742 | Heidelberg Retina Tomograph II / Rostock Cornea Module (HRT II / RCM) | Heidelberg Engineering | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 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?
The FDA summary names no predicate by number.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K971953 | Confoscan | 1997 | 2 |
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, K971953 (Tomey Corporation USA, 1997) has gone furthest, with 2 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 | — |
https://510kreport.com/device/K944910 · printed Nov 6, 2026
Cite this page
510(k) Report. “K944910: Tomey EM-1000 Specular Microscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K944910
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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