# K121128: Multipurpose Handling Medium

- Pathway: 510(k) (Traditional)
- Applicant: Irvine Scientific Sales Co., Inc.
- Decided: Jun 6, 2012 after 54 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 K021893 (2002). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983586: HTF Medium, Modified HTF Medium- Hepes, HTF Powder (Without Antibiotics), Modified HTG Powder- Hepes (Without Antiboditi, Irvine Scientific Sales Co., Inc. (1999) Summary page 1.
- K081115: G-Mops G5 Series, Vitrolife Sweden AB (2008) Summary page 1.

## Indications for use
Multipurpose Handling Medium (MHM) is intended for use in assisted reproductive procedures which involve the manipulation of gametes or embryos. Specifically, Multipurpose Handling Medium (MHM) is indicated for use as an oocyte retrieval medium during ovarian follicle aspiration procedures (not for flushing ovarian follicles), washing sperm prior to IVF and ICSI fertilization procedures, and for transport of the embryo to the uterus during embryo transfer procedures.

Source page: https://510kreport.com/device/K121128
Methodology: https://510kreport.com/methodology