# K190383: GM501 Wash

- Pathway: 510(k) (Traditional)
- Applicant: Hamilton Thorne, Inc.
- Decided: Sep 5, 2019 after 198 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: 1 generation back to K142991 (2015). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142991: LifeGlobal Global Total w/HSA, LifeGlobal Global Total for Fertilization w/HSA, LifeGlobal Global Total w/HEPES W/HSA, Life Global Group, LLC (2015) Summary page 4.

## Most influential descendants
- K192503: GM501 Wash with Phenol Red and Gentamicin (2020), 0 descendants of its own

## Indications for use
GM501 Wash 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 is not intended for use in transferring embryos into the uterine cavity.

Source page: https://510kreport.com/device/K190383
Methodology: https://510kreport.com/methodology