# K022352: HTF Plus with Hepes (HTF with Non-Essential Amino Acids)

- Pathway: 510(k) (Traditional)
- Applicant: <Genx> Intl., Inc.
- Decided: Aug 28, 2002 after 40 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
HTF Plus with HEPES (HTF with non-essential amino acids) is used as a holding media for human gametes and embryos for assisted reproduction.

Source page: https://510kreport.com/device/K022352
Methodology: https://510kreport.com/methodology