# K151706: Specular Microscope CEM- 530

- Pathway: 510(k) (Traditional)
- Applicant: Nidek Co., Ltd.
- Decided: Mar 17, 2016 after 267 days
- Product code: NQE (Microscope, Specular)
- Device class: 2
- Regulation: 21 CFR 886.1850
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K920906 (1992). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130565: Specular Microscope Cem-530, Nidek Co., Ltd. (2013) Summary page 4.
- K120264: Konan Specular Microscope Xiv, Konan Medical, Inc. (2012) Summary page 4.

## Most influential descendants
- K173980: Specular Microscope CEM-530 (2018), 0 descendants of its own

## 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)
- Aug 8, 2016 · Class II · Z-2711-2016: Software version 1.08 and 1.09 for the Specular Microscope CEM 530 included a change of analysis results feature that was not reviewed and approved by the FDA.

## Indications for use
The 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/K151706
Methodology: https://510kreport.com/methodology