510(k) · Cleared
ClearedEM-4000 Specular Microscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tomey Corporation · NQE Microscope, Specular
Cleared on Jan 19, 2018 as substantially equivalent to K120264 (Konan Medical, Inc., 2012) after a 260-day review. Its family tree reaches back 4 generations to 1992.
- Decided
- Jan 19, 2018
- Review
- 260 days
- Class
- Class II
- Product code
- NQE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K920906 (1992). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK920906 DGH-500 PachymeterDgh Technology, Inc. · 1992
- 3 generations backK980357 Konan Noncon Robo Pachy Specular Microscope and Opticl PachymeterKonan, Inc. · 1998
- 2 generations backK062763 Noncon Robo Pachy F&aKonan Medical, Inc. · 2008
- 1 generation backK120264 Konan Specular Microscope XivKonan Medical, Inc. · 2012
- This deviceK171313 EM-4000 Specular MicroscopeTomey Corporation · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K920906 | DGH-500 Pachymeter | Dgh Technology, Inc. | 1992 | — |
| −3 | K980357 | Konan Noncon Robo Pachy Specular Microscope and Opticl Pachymeter | Konan, Inc. | 1998 | — |
| −2 | K062763 | Noncon Robo Pachy F&a | Konan Medical, Inc. | 2008 | — |
| −1 | K120264 | Konan Specular Microscope Xiv | Konan Medical, Inc. | 2012 | — |
| 0 (this device) | K171313 | EM-4000 Specular Microscope | Tomey Corporation | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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 NQE? 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 NQE device
- #1 K191558 Konan Specular Microscope XVIIscore -0.0 · 4 generations · no Class I recall
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 |
|---|---|---|---|
| * | K120264 | Konan Specular Microscope XivSummary page 4…as Class II devices pursuant to 21 C.F.R. §886.1850. PRODUCT CODE: CLASSIFICATION / CFR TITLE NQE, 21 CFR 886.1850 PREDICATE DEVICES Konan Medical, Inc. Cellchek XL (K120264) INDICATIONS FOR USE The EM-4000 Specular Microscope is a non-contact ophthalmic microscope, optical pachymeter, and camera inte… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
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 26 years and passes through 4 companies; a new generation was cleared every 5.8 years on median.
- None of the 5 ancestors has a recall.
- 5 other devices also cite its predicate K120264.
How does its category compare?
All NQE devicesNQE Microscope, Specular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · NQE
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · NQE
Too few NQE 510(k)s in any year since 2007 to give a median.
Recalls per year · NQE
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NQE
No MAUDE report names NQE since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 0 | — | 1 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The EM-4000 Specular Microscope is a non-contact ophthalmic microscope, optical pachymeter, and camera intended for examination of the corneal endothelium and for measurement of the thickness of the cornea.
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/K171313 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171313: EM-4000 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/K171313
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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