# K160504: RI Witness Embryology Heated Plate

- Pathway: 510(k) (Traditional)
- Applicant: Research Instruments Limited
- Decided: Jul 18, 2016 after 145 days
- Product code: MQG (Accessory, Assisted Reproduction)
- Device class: 2
- Regulation: 21 CFR 884.6120
- 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: 1 generation back to K991263 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991263: Thermoplate, Tokai Hit Co., Ltd. (1999) Summary page 4.

## Recalls of this device
- Sep 5, 2019 · Class III · Z-0029-2020: The touchpad may not work properly after cleaning.

## Indications for use
To maintain the temperature of human reproductive tissue such as oocytes and embryos through an assisted reproduction (AR) cycle.

Source page: https://510kreport.com/device/K160504
Methodology: https://510kreport.com/methodology