510(k) · Cleared
ClearedWallace Dual Lumen Oocyte Retrieval Sets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Portex, Ltd. · MQE Needle, Assisted Reproduction
Cleared on Jun 26, 2003 as substantially equivalent to K983593 (Cook Ob/Gyn, 1999) after a 34-day review. Its family tree reaches back 1 generation to 1999. 3 later devices descend from it.
- Decided
- Jun 26, 2003
- Review
- 34 days
- Class
- Class II
- Product code
- MQE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K983593 (1999). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK983593 Ovum Pick-UP Aspiration NeedlesCook Ob/Gyn · 1999
- This deviceK031622 Wallace Dual Lumen Oocyte Retrieval SetsPortex, Ltd. · 2003
- Descendant · cites it directly · 2 of its ownK182959 Wallace Dual Lumen Oocyte Recovery SystemCooperSurgical, Inc. · 2019
- Descendant · 2 generations on · 1 of its ownK191291 Wallace Dual Lumen Oocyte Recovery SystemCooperSurgical, Inc. · 2019
- Descendant · 3 generations on · 0 of its ownK232163 Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum…Zhejiang Horizon Medical Technology Co., Ltd. · 2024
Most influential descendants
Showing 3 of 3 · See all- K182959Wallace Dual Lumen Oocyte Recovery SystemCooperSurgical, Inc. · 2019 · cites it directly2descendants
- K191291Wallace Dual Lumen Oocyte Recovery SystemCooperSurgical, Inc. · 2019 · 2 generations on1descendant
- K232163Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration NeedleZhejiang Horizon Medical Technology Co., Ltd. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K983593 | Ovum Pick-UP Aspiration Needles | Cook Ob/Gyn | 1999 | — |
| 0 (this device) | K031622 | Wallace Dual Lumen Oocyte Retrieval Sets | Portex, Ltd. | 2003 | — |
| +1 | K182959 | Wallace Dual Lumen Oocyte Recovery System | CooperSurgical, Inc. | 2019 | — |
| +2 | K191291 | Wallace Dual Lumen Oocyte Recovery System | CooperSurgical, Inc. | 2019 | — |
| +3 | K232163 | Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration… | Zhejiang Horizon Medical Technology Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2024 | 1 | 0 |
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
- #2 Held for the reportin the report
What was it cleared against? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K000628 | FDA’s K000628 is Wallace Oocyte Retrieval Set-16G, Model MEONS1633; Wallace Oocyte Retrieval… Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2000 |
| * | K983593 | Ovum Pick-UP Aspiration NeedlesSummary page 1…Wallace single lumen Oocyte Retrieval sets already marketed in the USA under KO0628 0 Cook Double Lumen Ovum Aspiration Needle, already marketed in the USA under K983593. DEVICE DESCRIPTION: The Wallace Dual Lumen Oocyte Retrieval Sets are sterile, single-use devices for ultrasound - guided tran… | 1999 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182959 | Wallace Dual Lumen Oocyte Recovery System | 2019 | 2 |
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?
How does its category compare?
All MQE devicesMQE Needle, Assisted Reproduction: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The Wallace Dual Lumen Oocyte Retrieval Sets are sterile single-use devices for ultrasonic-guided transvaginal collection of oocytes from the ovarian follicles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031622 · printed Nov 5, 2026
Cite this page
510(k) Report. “K031622: Wallace Dual Lumen Oocyte Retrieval Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031622
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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