510(k) · Cleared
ClearedConfoscan
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 Aug 14, 1997 as substantially equivalent to K912514 (Tandem Scanning Corp., 1991) and 2 other predicates after a 78-day review. Its family tree reaches back 1 generation to 1991. 2 later devices descend from it.
- Decided
- Aug 14, 1997
- Review
- 78 days
- Class
- Class II
- Product code
- HJO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K912514 (1991). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK912514 Tandem Scanning MicroscopeTandem Scanning Corp. · 1991
- This deviceK971953 ConfoscanTomey Corporation USA · 1997
- Descendant · cites it directly · 1 of its ownK012416 Confoscan 2 Confocal MicroscopeNidek Technologies Srl · 2001
- Descendant · 2 generations on · 0 of its ownK042742 Heidelberg Retina Tomograph II / Rostock Cornea Module (HRT II / RCM)Heidelberg Engineering · 2004
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 |
|---|---|---|---|---|---|
| −1 | K912514 | Tandem Scanning Microscope | Tandem Scanning Corp. | 1991 | — |
| 0 (this device) | K971953 | Confoscan | Tomey Corporation USA | 1997 | — |
| +1 | K012416 | Confoscan 2 Confocal Microscope | Nidek Technologies Srl | 2001 | — |
| +2 | 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 |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K912514 | Tandem Scanning MicroscopeSummary page 1…(FAX) April 1, 1996 A. LEGALLY MARKETED PREDICATE DEVICES Tandem Scanning Confocal Microscope as manufactured by Tandem Scanning Corporation, Reston VA (as cleared in K912514) Tomey EM-100 Specular Microscope by Tomey Corporation, Cambridge, MA (as cleared in K944910). Tomey Video Vision Analyzer, VRB… | 1991 |
| * | K944910 | Tomey EM-1000 Specular MicroscopeSummary page 1…pe as manufactured by Tandem Scanning Corporation, Reston VA (as cleared in K912514) Tomey EM-100 Specular Microscope by Tomey Corporation, Cambridge, MA (as cleared in K944910). Tomey Video Vision Analyzer, VRB 100 by Tomey Corporation, Cambridge, MA (as cleared in K945959). ConfoScan, Section VI ===… | 1994 |
| * | K945959 | Video Vision Analyzer (Viva), VRB 100Summary page 1…Specular Microscope by Tomey Corporation, Cambridge, MA (as cleared in K944910). Tomey Video Vision Analyzer, VRB 100 by Tomey Corporation, Cambridge, MA (as cleared in K945959). ConfoScan, Section VI DEVICE DESCRIPTION The Tomey "ConfoScan" Confocal Microscope is a scanning slit microsc… | 1995 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K012416 | Confoscan 2 Confocal Microscope | 2001 | 1 |
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?
- None of the 3 ancestors has a recall.
- Of its descendants, K012416 (Nidek Technologies Srl, 2001) has gone furthest, with 1 descendant 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 Tomey "ConfoScan" Confocal Microscope is intended for use as a diagnostic tool for looking at 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/K971953 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971953: Confoscan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971953
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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