# K193522: iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA

- Pathway: 510(k) (Traditional)
- Applicant: Kitazato Corporation
- Decided: Aug 25, 2020 after 250 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: 4 generations back to K034063 (2004). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170681: Continuous Single Culture -NX (CSCM-NX), Irvine Scientific Sales Co., Inc. (2017) Summary page 4.

## Indications for use
iMedium Single Step media are intended to be used as culture media for gametes and embryos from fertilization through day 5/6 of development. iMedium Single Step media are not intended for embryo transfer procedures.

Source page: https://510kreport.com/device/K193522
Methodology: https://510kreport.com/methodology