# K192503: GM501 Wash with Phenol Red and Gentamicin

- Pathway: 510(k) (Special)
- Applicant: Hamilton Thorne Incorporated
- Decided: Nov 19, 2020 after 434 days
- Product code: MQL (Media, Reproductive)
- Device class: 2
- Regulation: 21 CFR 884.6180
- 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 K142991 (2015). 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)
- K190383: GM501 Wash, Hamilton Thorne, Inc. (2019) Summary page 4.

## Indications for use
GM501 Wash with Phenol Red and Gentamicin is intended for in vitro procedures involving handling and micromanipulation of human oocytes and embryos outside of a CO2 incubator. Indications include oocyte and embryo washing (e.g. after oocyte aspiration, after hyaluronidase treatment to remove cumulus cells, before and after cryopreservation, and before embryo transfer) and micromanipulation procedures (e.g. assisted hatching). GM501 Wash with Phenol Red and Gentamicin is not intended for use in transferring embryos into the uterine cavity.

Source page: https://510kreport.com/device/K192503
Methodology: https://510kreport.com/methodology