# K173980: Specular Microscope CEM-530

- Pathway: 510(k) (Traditional)
- Applicant: Nidek Co., Ltd.
- Decided: Mar 14, 2018 after 75 days
- Product code: NQE (Microscope, Specular)
- Device class: 2
- Regulation: 21 CFR 886.1850
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K920906 (1992). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151706: Specular Microscope CEM- 530, Nidek Co., Ltd. (2016) Summary page 4.
- K120264: Konan Specular Microscope Xiv, Konan Medical, Inc. (2012) Summary page 4.

## Recalls of this device
- Feb 25, 2019 · Class III · Z-0771-2020: The electromagnetic noise exceeded the upper limit of the Electromagnetic Compatibility Standard (EMC: IEC 60601-1-2)

## Indications for use
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.

Source page: https://510kreport.com/device/K173980
Methodology: https://510kreport.com/methodology