# K170681: Continuous Single Culture -NX (CSCM-NX)

- Pathway: 510(k) (Traditional)
- Applicant: Irvine Scientific Sales Co., Inc.
- Decided: Jun 8, 2017 after 94 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 K034063 (2004). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121572: Continuous Single Culture Complete, Irvine Scientific Sales Co., Inc. (2012) Summary page 4.

## Most influential descendants
- K193522: iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA (2020), 0 descendants of its own

## Indications for use
The Continuous Single Culture®-NX (CSCM-NX) is intended for use as a culture medium for human gametes and embryos from fertilization through day 5/6 of development in vitro.

Source page: https://510kreport.com/device/K170681
Methodology: https://510kreport.com/methodology