510(k) · Cleared
ClearedLotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zhejiang Horizon Medical Technology Co., Ltd. · MQE Needle, Assisted Reproduction
Cleared on Feb 22, 2024 as substantially equivalent to K191291 (CooperSurgical, Inc., 2019) after a 216-day review. Its family tree reaches back 4 generations to 1999.
- Decided
- Feb 22, 2024
- Review
- 216 days
- Class
- Class II
- Product code
- MQE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K983593 (1999). No later device cites it as a predicate yet.
- Root · 4 generations backK983593 Ovum Pick-UP Aspiration NeedlesCook Ob/Gyn · 1999
- 3 generations backK031622 Wallace Dual Lumen Oocyte Retrieval SetsPortex, Ltd. · 2003
- 2 generations backK182959 Wallace Dual Lumen Oocyte Recovery SystemCooperSurgical, Inc. · 2019
- 1 generation backK191291 Wallace Dual Lumen Oocyte Recovery SystemCooperSurgical, Inc. · 2019
- This deviceK232163 Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum…Zhejiang Horizon Medical Technology Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K983593 | Ovum Pick-UP Aspiration Needles | Cook Ob/Gyn | 1999 | — |
| −3 | K031622 | Wallace Dual Lumen Oocyte Retrieval Sets | Portex, Ltd. | 2003 | — |
| −2 | K182959 | Wallace Dual Lumen Oocyte Recovery System | CooperSurgical, Inc. | 2019 | — |
| −1 | K191291 | Wallace Dual Lumen Oocyte Recovery System | CooperSurgical, Inc. | 2019 | — |
| 0 (this device) | K232163 | Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration… | Zhejiang Horizon Medical Technology Co., Ltd. | 2024 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MQE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MQE device
- #1 K240523 VitaVitro® Single Lumen Oocyte Retrieval…score 8.4 · 1 generation · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K191291 | Wallace Dual Lumen Oocyte Recovery SystemSummary page 5…Class II 5. Predicate Device Information Device Name: Wallace Dual Lumen Oocyte Recovery System 510(k) Number: K191291 Sponsor: CooperSurgical Inc. The predicate device has not been subject to a design-related recal… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 4.7 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All MQE devicesMQE Needle, Assisted Reproduction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · MQE
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MQE
197in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQE
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQE
37in 2025
MAUDE reports naming product code MQE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 1 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 1 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 18 |
| 2017 | 4 | 234 | 0 | 3 |
| 2018 | 1 | — | 0 | 5 |
| 2019 | 3 | 197 | 0 | 5 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 37 |
| 2024 | 2 | — | 0 | 20 |
| 2025 | 0 | — | 0 | 37 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232163 · printed Nov 5, 2026
Cite this page
510(k) Report. “K232163: Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K232163
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026