# K152932: BlastGen

- Pathway: 510(k) (Traditional)
- Applicant: Origio A/S
- Decided: Feb 29, 2016 after 147 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 K003156 (2001). 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)
- K133387: Origio (R) Sequential Blast TM; Origio (R) Sequential Blast TM with Phenol Red, Origio A/S (2014) Summary page 4.

## Indications for use
BlastGen™ is for the culture of embryos from the 4-8 cell stage through to the blastocyst stage. BlastGen™ can also be used for embryo transfer.

Source page: https://510kreport.com/device/K152932
Methodology: https://510kreport.com/methodology