# K232163: Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle

- Pathway: 510(k) (Traditional)
- Applicant: Zhejiang Horizon Medical Technology Co., Ltd.
- Decided: Feb 22, 2024 after 216 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: 4 generations back to K983593 (1999). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191291: Wallace Dual Lumen Oocyte Recovery System, CooperSurgical, Inc. (2019) Summary page 5.

## Indications for use
Lotus Single Lumen Ovum Aspiration Needle is used for ultrasound guided transvaginal aspiration of oocytes from ovarian follicles for patients undergoing Assisted Reproductive procedures. Lotus Double Lumen Ovum Aspiration Needle is used for ultrasound guided transvaginal aspiration and flushing of oocytes from ovarian follicles for patients undergoing Assisted Reproductive procedures.

Source page: https://510kreport.com/device/K232163
Methodology: https://510kreport.com/methodology