# K191020: G210 InviCell Plus with SignipHy pH monitoring

- Pathway: 510(k) (Traditional)
- Applicant: CooperSurgical, Inc.
- Decided: Jan 14, 2020 after 272 days
- Product code: PUB (Accessory, Assisted Reproduction, Exempt)
- Device class: 2
- Regulation: 21 CFR 884.6120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K983642 (1999). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121566: Planer BT37 Incubator, Planer Plc (2012) Summary page 4.

## Indications for use
The G210 InviCell Plus with SignipHy™ pH Monitoring System is a bench-top incubator that is intended to provide a controlled environment at or near body temperature and gas levels (CO2, O2, and N2) for the development of gametes and/or embryos during In Vitro Fertilization (IVF) / Assisted Reproductive Technology (ART) treatments. The G210 InviCell Plus with SignipHy™ pH Monitoring System includes an accessory for pH monitoring of surrogate samples of bicarbonate-based culture media used for ART procedures.

Source page: https://510kreport.com/device/K191020
Methodology: https://510kreport.com/methodology