# K242107: CaseMONO™ Culture  (CMON); CaseMONO™ w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES (HHTF)

- Pathway: 510(k) (Traditional)
- Applicant: Casebioscience, Inc.
- Decided: Mar 21, 2025 after 246 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 K240149 (2024). 1 ancestor in all.
1 later device descends 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)
- K240149: Giftlife™ Fertilization Medium; Giftlife™ Cleavage Medium; Giftlife™ Blastocyst Medium; Giftlife™ Single Step Medium, Gimbo Medical Technology Shenzhen Co., Ltd. (2024) Summary page 5.

## Most influential descendants
- K252672: CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5) (2026), 0 descendants of its own

## Indications for use
CaseMONO™ Culture is intended for use for culture of embryos from fertilization to the blastocyst stage. This device can be used for transfer of embryos to the uterus. CaseBioscience® HTF is intended for use for the culture of embryos to the cleavage stage (Day 3). This device can be used for transfer of embryos to the uterus. CaseMONO w/HEPES™ is intended for use in short-term handling and manipulating gametes and embryos, including washing and intracytoplasmic sperm injection (ICSI). This medium is not intended for transferring embryos to the uterine cavity. CaseBioscience® HTF w/HEPES is intended for use in short-term handling and manipulating gametes embryos, including washing and intracytoplasmic sperm injection (ICSI). This medium is not intended for transferring embryos to the uterine cavity.

Source page: https://510kreport.com/device/K242107
Methodology: https://510kreport.com/methodology