# K192644: GM501 SpermAir and GM501 SpermActive

- Pathway: 510(k) (Traditional)
- Applicant: Hamilton Thorne Incorporated
- Decided: Apr 23, 2020 after 212 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: 3 generations back to K002383 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190199: SepaSperm Washing Solution, SepaSperm Solution, Kitazato Corporation (2019). Cleared while this submission was under review Summary page 4.

## Indications for use
GM501 SpermAir is intended for the handling and preparation of sperm for use in assisted reproduction procedures. GM501 SpermAir is not intended for use in intrauterine insemination procedures. GM501 SpermActive is intended for the handling and preparation of sperm for use in assisted reproduction procedures. GM501 SpermActive is not intended for use in intrauterine insemination procedures.

Source page: https://510kreport.com/device/K192644
Methodology: https://510kreport.com/methodology