# K142991: LifeGlobal Global Total w/HSA, LifeGlobal Global Total for Fertilization w/HSA, LifeGlobal Global Total w/HEPES W/HSA

- Pathway: 510(k) (Traditional)
- Applicant: Life Global Group, LLC
- Decided: Feb 17, 2015 after 124 days
- Product code: MQL (Media, Reproductive)
- Device class: 2
- Regulation: 21 CFR 884.6180
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K200408: VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium (2020), 1 descendant of its own
- K190383: GM501 Wash (2019), 1 descendant of its own
- K251637: Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA]) (2025), 0 descendants of its own
- K213293: V-Hepes Plus (2022), 0 descendants of its own
- K192503: GM501 Wash with Phenol Red and Gentamicin (2020), 0 descendants of its own

## Recalls of this device
- Dec 20, 2023 · Class II · Z-1089-2024: The firm has become aware of a sudden increase in complaints for three associated lots. Performance issues may lead to impaired embryo development prior to the blastocyst stage.
- Feb 13, 2023 · Class II · Z-1348-2023: It has come to CooperSurgical's attention that the affected Product may contain a medium other than the Global Total LP single step medium which does not contain the protein source required for embryo

## Indications for use
Culture of Embryos from zygote to blastocyst, embryo transfer Oocyte culture and fertilization Oocyte and embryo washing, Manipulation, fertilization by intracytoplasmic sperm injection (ICSI), embryo transfer

Source page: https://510kreport.com/device/K142991
Methodology: https://510kreport.com/methodology