510(k) · Cleared
ClearedSP-1PSpecular Microscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Topcon Corporation · NQE Microscope, Specular
Cleared on May 29, 2015 as substantially equivalent to K120264 (Konan Medical, Inc., 2012) after a 274-day review. Its family tree reaches back 4 generations to 1992. 1 later device descends from it.
- Decided
- May 29, 2015
- Review
- 274 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. 1 later device descends from it, 1 citing it directly.
- 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 deviceK142417 SP-1PSpecular MicroscopeTopcon Corporation · 2015
- Descendant · cites it directly · 0 of its ownK253039 Auto Kerato-Refracto Tonometer TRK-3 OmniaTopcon Corporation · 2025
Most influential descendants
Showing 1 of 1 · See all- K253039Auto Kerato-Refracto Tonometer TRK-3 OmniaTopcon Corporation · 2025 · cites it directly0descendants
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) | K142417 | SP-1PSpecular Microscope | Topcon Corporation | 2015 | — |
| +1 | K253039 | Auto Kerato-Refracto Tonometer TRK-3 Omnia | Topcon Corporation | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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…cular Classification Name AC-powered slitlamp biomicroscope 21 C.F.R. 886.1850 Class II Product Code: NQE Predicate Device Konan Specular Microscope Xiv Cellchek Plus (K120264) Device Description This instrument is a photographic device dedicated to photograph and record corneal endothelial cells as an… | 2012 |
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 |
|---|---|---|---|
| K253039 | Auto Kerato-Refracto Tonometer TRK-3 Omnia | 2025 | 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 23 years and passes through 4 companies; a new generation was cleared every 5.5 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K253039 (Topcon Corporation, 2025) has gone furthest, with 0 descendants of its own.
- 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. 2015, 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 Specular Microscope SP-1P is a non-contact ophthalmic microscope, optical pachymeter, and camera intended for examination of corneal endothelium and for measurement of the thickness of the cornea.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142417 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142417: SP-1PSpecular Microscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142417
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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