# K991420: Modified Ham's F-10 with Albumin

- Pathway: 510(k) (Traditional)
- Applicant: Irvine Scientific Sales Co., Inc.
- Decided: Jul 2, 1999 after 70 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
Modified Ham's F-10 with Albumin is intended for assisted reproduction procedures such as the processing or manipulation of human sperm prior to insemination, in vitro fertilization and intracytoplasmic sperm injection (ICS!) procedures.

Source page: https://510kreport.com/device/K991420
Methodology: https://510kreport.com/methodology