510(k) · Cleared
Recalled · 2008Wallace Oocyte Retrieval Sets 16G, Wallace Oocyte Retrieval Set 17G, Models Meons 1633S, Meons 1733S
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sims Portex, Ltd. · MQE Needle, Assisted Reproduction
Cleared on Aug 3, 2001 after a 32-day review. The FDA summary names no predicate by number. 1 later device descends from it. It has been recalled once.
- Decided
- Aug 3, 2001
- Review
- 32 days
- Class
- Class II
- Product code
- MQE
- Recalls
- 1
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK012068 Wallace Oocyte Retrieval Sets 16G, Wallace Oocyte Retrieval Set 17G…Sims Portex, Ltd. · 2001
- Descendant · cites it directly · 0 of its ownK023930 Coopersurgical Oocyte Recovery NeedlesCooperSurgical, Inc. · 2003
Most influential descendants
Showing 1 of 1 · See all- K023930Coopersurgical Oocyte Recovery NeedlesCooperSurgical, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K012068 | Wallace Oocyte Retrieval Sets 16G, Wallace Oocyte Retrieval Set 17G, Models… | Sims Portex, Ltd. | 2001 | — |
| +1 | K023930 | Coopersurgical Oocyte Recovery Needles | CooperSurgical, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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 8.3 · 1 generation · no Class I recall
- #2 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023930 | Coopersurgical Oocyte Recovery Needles | 2003 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 23, 2008 | Not classified | Z-0593-2009 | Packaging | Smiths Medical International became aware that certain lots of Wallace oocyte Recovery Sets have a damaged needle tip. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K023930 (CooperSurgical, Inc., 2003) has gone furthest, with 0 descendants of its own.
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 Oocyte Retrieval Sets are sterile, single-use devices intended for ultrasound-guided,
transvaginal collection of oocytes for ovarian follicles.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012068 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012068: Wallace Oocyte Retrieval Sets 16G, Wallace Oocyte Retrieval Set 17G, Models Meons 1633S, Meons 1733S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012068
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026