# K990941: Newlife Dish (Etched or Non-Etched, with or Without Lid), Models 14-52, 1452E, 1452EL, 1452L

- Pathway: 510(k) (Traditional)
- Applicant: Humagen Fertility Diagnostics, Inc.
- Decided: Jul 14, 1999 after 114 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.
11 later devices descend from it; 1 cites it directly.
0 of 12 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
- K090429: Nunc Ivf Centerwell and Icsi Dishes (2009), 10 descendants of its own
- K112413: RI MSC (Migration Sedimentation Chamber) (2012), 7 descendants of its own
- K133295: Qualis (2014), 5 descendants of its own
- K173075: ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml) (2018), 4 descendants of its own
- 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

## Indications for use
The NewLife Dish's indication for use is to hold zygotes/embfyos during micromanipulation or other tissue culture procedures in the IVF laboratory. NewLife Dishes are used in the tissue culture techniques performed by embryologists when injecting a single sperm into an egg, or assisting an embryo in hatching prior to re-implantation. The dishes are disposable tissue culture labware used in procedures that have been developed to aid infertile couples achieve pregnancy. Specifically, the ICSI procedure is beneficial in cases where the male infertility is impaired.

Source page: https://510kreport.com/device/K990941
Methodology: https://510kreport.com/methodology