# K191552: GM501 Mineral Oil

- Pathway: 510(k) (Abbreviated)
- Applicant: Hamilton Thorne, Inc.
- Decided: Sep 18, 2019 after 98 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 K011462 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053494: Oil for Tissue Culture, Gradient System and Spermfreeze, Fertipro NV (2006) Summary page 4.

## Indications for use
GM501 Mineral Oil is intended for use as an overlay for culture of gametes, zygotes, or embryos in Assisted Reproduction Technology (ART) and micro-manipulation procedures.

Source page: https://510kreport.com/device/K191552
Methodology: https://510kreport.com/methodology