# K031622: Wallace Dual Lumen Oocyte Retrieval Sets

- Pathway: 510(k) (Traditional)
- Applicant: Portex, Ltd.
- Decided: Jun 26, 2003 after 34 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: 1 generation back to K983593 (1999). 1 ancestor in all.
3 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)
- K983593: Ovum Pick-UP Aspiration Needles, Cook Ob/Gyn (1999) Summary page 1.

## Cited in the summary but kept off the family tree
- K000628: Wallace Oocyte Retrieval Set-16G, Model MEONS1633; Wallace Oocyte Retrieval Set-17G, Model MEONS1733, Sims Portex, Ltd. (2000). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K182959: Wallace Dual Lumen Oocyte Recovery System (2019), 2 descendants of its own
- 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 Retrieval Sets are sterile single-use devices for ultrasonic-guided transvaginal collection of oocytes from the ovarian follicles.

Source page: https://510kreport.com/device/K031622
Methodology: https://510kreport.com/methodology