# K003156: Blastassist System

- Pathway: 510(k) (Traditional)
- Applicant: Medicult A/S
- Decided: Mar 22, 2001 after 163 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
No predicates in its family tree.
7 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K061309: Embryoassist (2007), 3 descendants of its own
- K080172: Blastassist Without Phenol Red, Model Ref 1215, Blastassist with Phenol Red, Model Ref 1216 (2008), 2 descendants of its own
- K080473: Embryoassist and Embryoassist with Phenol Red (2008), 2 descendants of its own
- K133387: Origio (R) Sequential Blast TM; Origio (R) Sequential Blast TM with Phenol Red (2014), 1 descendant of its own
- K120136: Embryogen (2012), 1 descendant of its own

Source page: https://510kreport.com/device/K003156
Methodology: https://510kreport.com/methodology