# K080172: Blastassist Without Phenol Red, Model Ref 1215, Blastassist with Phenol Red, Model Ref 1216

- Pathway: 510(k) (Traditional)
- Applicant: Medicult A/S
- Decided: Dec 18, 2008 after 329 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: 1 generation back to K003156 (2001). 1 ancestor in all.
2 later devices descend 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)
- K003156: Blastassist System, Medicult A/S (2001) Summary page 1.

## Most influential descendants
- K133387: Origio (R) Sequential Blast TM; Origio (R) Sequential Blast TM with Phenol Red (2014), 1 descendant of its own
- K152932: BlastGen (2016), 0 descendants of its own

## Indications for use
BlastAssist® is for culture from the 4-8 cell stage through to blastocyst stage. Can also be used for embryo transfer. BlastAssist® with Phenol Red is for culture from the 4-8 cell stage through to blastocyst stage. Can also be used for embryo transfer.

Source page: https://510kreport.com/device/K080172
Methodology: https://510kreport.com/methodology