# K991251: Falcon Ivf One Well Dish

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson Labware
- Decided: May 5, 1999 after 22 days
- Product code: MQK (Labware, Assisted Reproduction)
- Device class: 2
- Regulation: 21 CFR 884.6160
- 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. The FDA summary names no predicate by number.

## Most influential descendants
- K123641: Culture Dish 40 MM, Culture Dish 60 MM, Micro Droplet Culture Dish, 5 Well Culture Dish, Centre Well Dish, Icsi Dish (2013), 1 descendant of its own
- K150756: Micro well group culture dish, 9-well; Micro well group culture dish, 16-well (2015), 0 descendants of its own

## Indications for use
The FALCON® IVF One Well Dish is sterile, nonpyrogenic, embryotoxicity tested, single-use plasticware intended to prepare, store, manipulate, or transfer human gametes or embryos for in vitro fertilization (IVF) or other assisted reproduction techniques.

Source page: https://510kreport.com/device/K991251
Methodology: https://510kreport.com/methodology