# K133387: Origio (R) Sequential Blast TM; Origio (R) Sequential Blast TM with Phenol Red

- Pathway: 510(k) (Traditional)
- Applicant: Origio A/S
- Decided: Apr 29, 2014 after 175 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 K003156 (2001). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080172: Blastassist Without Phenol Red, Model Ref 1215, Blastassist with Phenol Red, Model Ref 1216, Medicult A/S (2008) Summary page 1.

## Most influential descendants
- K152932: BlastGen (2016), 0 descendants of its own

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

Source page: https://510kreport.com/device/K133387
Methodology: https://510kreport.com/methodology