# K182959: Wallace Dual Lumen Oocyte Recovery System

- Pathway: 510(k) (Traditional)
- Applicant: CooperSurgical, Inc.
- Decided: May 10, 2019 after 197 days
- Product code: MQE (Needle, Assisted Reproduction)
- Device class: 2
- Regulation: 21 CFR 884.6100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K983593 (1999). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031622: Wallace Dual Lumen Oocyte Retrieval Sets, Portex, Ltd. (2003) Summary page 4.

## Most influential descendants
- K191291: Wallace Dual Lumen Oocyte Recovery System (2019), 1 descendant of its own
- K232163: Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle (2024), 0 descendants of its own

## Indications for use
The Wallace Dual Lumen Oocyte Recovery System is a sterile, single-use device for ultrasonic-guided transvaginal collection of oocytes from the ovarian follicles.

Source page: https://510kreport.com/device/K182959
Methodology: https://510kreport.com/methodology