# K121572: Continuous Single Culture Complete

- Pathway: 510(k) (Traditional)
- Applicant: Irvine Scientific Sales Co., Inc.
- Decided: Jul 19, 2012 after 51 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 K034063 (2004). 3 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072609: Single Step Medium, Irvine Scientific Sales Co., Inc. (2008) Summary page 1.

## Most influential descendants
- K133568: G-TL (2014), 4 descendants of its own
- K191063: 1-Step Culture Medium (2019), 1 descendant of its own
- K170681: Continuous Single Culture -NX (CSCM-NX) (2017), 1 descendant of its own
- K202862: Gx-IVF, Gx-TL, Gx-MOPS PLUS (2021), 0 descendants of its own
- K193285: V-Onestep (2020), 0 descendants of its own

## Indications for use
Continuous Single Culture TM Complete 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/K121572
Methodology: https://510kreport.com/methodology