510(k) · Cleared
Recalled · Class III · 2019Specular Microscope CEM-530
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nidek Co., Ltd. · NQE Microscope, Specular
Cleared on Mar 14, 2018 as substantially equivalent to K151706 (Nidek Co., Ltd., 2016) and 1 other predicate after a 75-day review. Its family tree reaches back 6 generations to 1992. It has been recalled once.
- Decided
- Mar 14, 2018
- Review
- 75 days
- Class
- Class II
- Product code
- NQE
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 6 generations to K920906 (1992). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK920906 DGH-500 PachymeterDgh Technology, Inc. · 1992
- 5 generations backK980357 Konan Noncon Robo Pachy Specular Microscope and Opticl PachymeterKonan, Inc. · 1998
- 4 generations backK062763 Noncon Robo Pachy F&aKonan Medical, Inc. · 2008
- 3 generations backK120264 Konan Specular Microscope XivKonan Medical, Inc. · 2012
- 2 generations backK130565 Specular Microscope Cem-530Nidek Co., Ltd. · 2013 · Recalled
- 1 generation backK151706 Specular Microscope CEM- 530Nidek Co., Ltd. · 2016 · Recalled
- This deviceK173980 Specular Microscope CEM-530Nidek Co., Ltd. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K920906 | DGH-500 Pachymeter | Dgh Technology, Inc. | 1992 | — |
| −5 | K980357 | Konan Noncon Robo Pachy Specular Microscope and Opticl Pachymeter | Konan, Inc. | 1998 | — |
| −4 | K062763 | Noncon Robo Pachy F&a | Konan Medical, Inc. | 2008 | — |
| −3 | K120264 | Konan Specular Microscope Xiv | Konan Medical, Inc. | 2012 | — |
| −2 | K130565 | Specular Microscope Cem-530 | Nidek Co., Ltd. | 2013 | 1 |
| −1 | K151706 | Specular Microscope CEM- 530 | Nidek Co., Ltd. | 2016 | 2 |
| 0 (this device) | K173980 | Specular Microscope CEM-530 | Nidek Co., Ltd. | 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? (2)
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 |
|---|---|---|---|
| * | K151706 | Specular Microscope CEM- 530Summary page 4…s Class II devices pursuant to 21 C.F.R. §886.1850. PRODUCT CODE: CLASSIFICATION / CFR TITLE NQE, 21 CFR 886.1850 PREDICATE DEVICES NIDEK Specular Microscope CEM-530 (K151706) Konan Medical, Inc. Cellchek Plus (K120264) Page 1… | 2016 |
| * | K120264 | Konan Specular Microscope XivSummary page 4…6.1850. PRODUCT CODE: CLASSIFICATION / CFR TITLE NQE, 21 CFR 886.1850 PREDICATE DEVICES NIDEK Specular Microscope CEM-530 (K151706) Konan Medical, Inc. Cellchek Plus (K120264) Page 1 of 18… | 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 25, 2019 | Class III | Z-0771-2020 | Device Design | The electromagnetic noise exceeded the upper limit of the Electromagnetic Compatibility Standard (EMC: IEC 60601-1-2) |
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 4.1 years on median.
- 2 of the 7 ancestors have a recall of any class.
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 NIDEK Specular Microscope CEM-530 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 as stated in the FDA summary.
https://510kreport.com/device/K173980 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173980: Specular Microscope CEM-530.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173980
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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