# K190198: Microperimeter MP-3, Microperimeter MP-3 Type S

- Pathway: 510(k) (Traditional)
- Applicant: Nidek Co., Ltd.
- Decided: Apr 1, 2019 after 56 days
- Product code: HKI (Camera, Ophthalmic, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.1120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K941234 (1995). 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)
- K061768: MP-1 Microperimeter, Nidek Technologies Srl (2006) Summary page 4.
- K152729: Microperimeter MP-3, Nidek Co., Ltd. (2016) Summary page 4.

## Indications for use
The MICROPERIMETER MP-3 and MICROPERIMETER MP-3 Type S are indicated for use as: Color retinography Fixation examiner Fundus-related microperimetry Visual rehabilitation

Source page: https://510kreport.com/device/K190198
Methodology: https://510kreport.com/methodology