510(k) · Cleared
ClearedAllwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup Needle, ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line, ACE-M Manual Single Lumen Ovum Pickup Needle)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Allwin Medical Devices, Inc. · MQE Needle, Assisted Reproduction
Cleared on Nov 25, 2019 after a 263-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Nov 25, 2019
- Review
- 263 days
- Class
- Class II
- Product code
- MQE
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All MQE devicesMQE Needle, Assisted Reproduction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
Allwin Ovum Pickup Needles are used for laparoscopic or ultrasound guided transvaginal retrieval of oocytes from ovarian follicles.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K190590 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190590: Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup Needle, ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line, ACE-M Manual Single Lumen Ovum Pickup Needle).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190590
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026