510(k) · Cleared
ClearedConfoscan 2 Confocal Microscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nidek Technologies Srl · HJO Biomicroscope, Slit-Lamp, Ac-Powered
Cleared on Oct 26, 2001 as substantially equivalent to K971953 (Tomey Corporation USA, 1997) after an 88-day review. Its family tree reaches back 2 generations to 1991. 1 later device descends from it.
- Decided
- Oct 26, 2001
- Review
- 88 days
- Class
- Class II
- Product code
- HJO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K912514 (1991). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK912514 Tandem Scanning MicroscopeTandem Scanning Corp. · 1991
- 1 generation backK971953 ConfoscanTomey Corporation USA · 1997
- This deviceK012416 Confoscan 2 Confocal MicroscopeNidek Technologies Srl · 2001
- Descendant · cites it directly · 0 of its ownK042742 Heidelberg Retina Tomograph II / Rostock Cornea Module (HRT II / RCM)Heidelberg Engineering · 2004
Most influential descendants
Showing 1 of 1 · See all- K042742Heidelberg Retina Tomograph II / Rostock Cornea Module (HRT II / RCM)Heidelberg Engineering · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K912514 | Tandem Scanning Microscope | Tandem Scanning Corp. | 1991 | — |
| −1 | K971953 | Confoscan | Tomey Corporation USA | 1997 | — |
| 0 (this device) | K012416 | Confoscan 2 Confocal Microscope | Nidek Technologies Srl | 2001 | — |
| +1 | K042742 | Heidelberg Retina Tomograph II / Rostock Cornea Module (HRT II / RCM) | Heidelberg Engineering | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K971953 | Confoscan Our OCR of the scanned summary read K972953, FDA’s number for Palaurex 76KF (Aurex Precious Metal Industries (Pty)Ltd). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “ConfoScan Confocal Microscope”. | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042742 | Heidelberg Retina Tomograph II / Rostock Cornea Module (HRT II / RCM) | 2004 | 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?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 5.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K042742 (Heidelberg Engineering, 2004) has gone furthest, with 0 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 | — |
What is it indicated for?
The ConfoScan 2 Confocal Microscope is indicated for use as a diagnostic tool for observation of the cell layers of the anterior parts of the eye.
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/K012416 · printed Nov 5, 2026
Cite this page
510(k) Report. “K012416: Confoscan 2 Confocal Microscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012416
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026