# K991419: Modified Ham's F-10 Basal Medium, Modified Hams's F-10 Basal Medium Hepes, Modified Ham's F-10 Supplement (50X) Iyophili

- Pathway: 510(k) (Traditional)
- Applicant: Irvine Scientific Sales Co., Inc.
- Decided: Sep 14, 1999 after 144 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
Complete Modified Ham's F-10 Medium and Complete Modified Ham's F-10 Medium HEPES are intended for use in assisted reproductive technology procedures that involve the manipulation of gametes or embryos. Specifically, Complete Modified Ham’s F-10 Medium is intended for use as a culture medium for the embryo after fertilization, when used with an incubator, and as a medium to support in vitro fertilization. Complete Modified Ham’s F-10 Medium HEPES is intended for use as a sperm-processing medium in washing or ICSt-# - procedures, as an cocyte retrieval medium, for transport of the embryo, and as a support medium for implantation of the embryo. Both Modified Ham’s F-10 Medium and Modified Ham's F-10 Medium HEPES are supplied to customers as liquid basal media and 50X lyophilized supplements. Users are instructed to reconstitute the lyophilized supplement with the basal liquid media to form the complete media at the time of use.

Source page: https://510kreport.com/device/K991419
Methodology: https://510kreport.com/methodology