# K993484: Q-HTF, Cat# 2001

- Pathway: 510(k) (Traditional)
- Applicant: Invitrocare, Inc.
- Decided: May 25, 2000 after 224 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: 1 generation back to K983586 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 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.

## Indications for use
Q-HTF Medium is intended for use in assisted reproductive technology procedures that involve the manipulation of gametes and embryos. Specifically, Q-HTF 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. Q-HTF is intended to simulate the substances found in the human, female reproductive system.

Source page: https://510kreport.com/device/K993484
Methodology: https://510kreport.com/methodology