# K240149: Giftlife™ Fertilization Medium; Giftlife™ Cleavage Medium; Giftlife™ Blastocyst Medium; Giftlife™ Single Step Medium

- Pathway: 510(k) (Traditional)
- Applicant: Gimbo Medical Technology Shenzhen Co., Ltd.
- Decided: Jun 13, 2024 after 146 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 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
- K242107: CaseMONO™ Culture  (CMON); CaseMONO™ w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES (HHTF) (2025), 1 descendant of its own
- K252672: CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5) (2026), 0 descendants of its own

## Indications for use
Giftlife Fertilization Medium is intended for use during in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI) procedures and culture to the two pronuclei (zygote) stage of development. Giftlife Cleavage Medium is intended for use during in vitro fertilization (IVF) for culture of embryos from pronucleate stage to day 2 or day 3. This medium is not intended for transferring embryos to the uterine cavity. Giftlife Blastocyst Medium is intended for use during in vitro fertilization (IVF) for culture of embryos from day 3 to the blastocyst stage. This medium is not intended for transferring embryos to the uterine cavity. Giftlife Single Step Medium is used for culture of embryos from fertilization to the blastocyst stage.

Source page: https://510kreport.com/device/K240149
Methodology: https://510kreport.com/methodology