# K252672: CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5)

- Pathway: 510(k) (Traditional)
- Applicant: Casebioscience, Inc.
- Decided: Feb 20, 2026 after 179 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: 2 generations back to K240149 (2024). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242107: CaseMONO™ Culture  (CMON); CaseMONO™ w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES (HHTF), Casebioscience, Inc. (2025) Summary page 5.

## Indications for use
CaseBio™ Culture w/HSA 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. CaseBio™ Handling w/HSA 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.

Source page: https://510kreport.com/device/K252672
Methodology: https://510kreport.com/methodology