# K991395: Quinn's HTF Medium, Quinn's HTF Medium with Hepes, Quinn's Basal XI HTF Medium, Quinn's D3+ HTF Medium

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Reproductive Technologies
- Decided: Feb 15, 2000 after 300 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices 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.

## Most influential descendants
- K200408: VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium (2020), 1 descendant of its own
- K251637: Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA]) (2025), 0 descendants of its own

## Indications for use
Media for Embryo Preparation products that are used for assisted reproduction procedures. These media come in direct physical contact with human gametes or embryos for the purposes of preparation, maintenance, transfer or storage. Quinn's® HTF Medium was developed for in vitro fertilization and procedures involving the culture of early cleavage stage mammalian embryos. Quinn's® HTF Medium with HEPES was developed for in vitro procedures involving manipulations of gametes and embryos not requiring the use of a CO₂ incubator. Such procedures include oocyte recovery, gamete washing, micromanipulation, embryo transfer and cryopreservation. Quinn's® Basal XI HTF Medium was developed for in vitro procedures involving the culture of early cleavage stage mammalian embryos. This is the medium for culture of embryos from Day 1 through to Day 3. Quinn's® D3+ Medium was developed for in vitro procedures involving the culture of early cleavage stage mammalian embryos. This is the medium for culture of embryos after Day 3 of development.

Source page: https://510kreport.com/device/K991395
Methodology: https://510kreport.com/methodology