510(k) · Cleared
Recalled · 2008Wallace Oocyte Retrieval Set-16G, Model MEONS1633; Wallace Oocyte Retrieval Set-17G, Model MEONS1733
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 Mar 13, 2000 after an 18-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled once.
- Decided
- Mar 13, 2000
- Review
- 18 days
- Class
- Class II
- Product code
- MQE
- Recalls
- 1
- Predicates
- 0
FDA has not posted a summary or statement for it, so its predicates are not known.
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it?
No later submission names this one as a predicate yet.
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.
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 | — |
https://510kreport.com/device/K000628 · printed Nov 6, 2026
Cite this page
510(k) Report. “K000628: Wallace Oocyte Retrieval Set-16G, Model MEONS1633; Wallace Oocyte Retrieval Set-17G, Model MEONS1733.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000628
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026