510(k) · Cleared
ClearedOvum Pick-UP Aspiration Needles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Ob/Gyn · MQE Needle, Assisted Reproduction
Cleared on Jan 21, 1999 after a 100-day review. The FDA summary names its predicate without a number. 8 later devices descend from it.
- Decided
- Jan 21, 1999
- Review
- 100 days
- Class
- Class II
- Product code
- MQE
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 5 citing it directly.
- This deviceK983593 Ovum Pick-UP Aspiration NeedlesCook Ob/Gyn · 1999
- Descendant · cites it directly · 3 of its ownK031622 Wallace Dual Lumen Oocyte Retrieval SetsPortex, Ltd. · 2003
- Descendant · 2 generations on · 2 of its ownK182959 Wallace Dual Lumen Oocyte Recovery SystemCooperSurgical, Inc. · 2019
- Descendant · 3 generations on · 1 of its ownK191291 Wallace Dual Lumen Oocyte Recovery SystemCooperSurgical, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK240523 VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G…Shenzhen Vitavitro Biotech Co., Ltd. · 2024
- Descendant · 4 generations on · 0 of its ownK232163 Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum…Zhejiang Horizon Medical Technology Co., Ltd. · 2024
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K031622Wallace Dual Lumen Oocyte Retrieval SetsPortex, Ltd. · 2003 · cites it directly3descendants
- K182959Wallace Dual Lumen Oocyte Recovery SystemCooperSurgical, Inc. · 2019 · 2 generations on2descendants
- K191291Wallace Dual Lumen Oocyte Recovery SystemCooperSurgical, Inc. · 2019 · 3 generations on1descendant
- K240523VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double…Shenzhen Vitavitro Biotech Co., Ltd. · 2024 · cites it directly0descendants
- K232163Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration NeedleZhejiang Horizon Medical Technology Co., Ltd. · 2024 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983593 | Ovum Pick-UP Aspiration Needles | Cook Ob/Gyn | 1999 | — |
| +1 | K031622 | Wallace Dual Lumen Oocyte Retrieval Sets | Portex, Ltd. | 2003 | — |
| +2 | K182959 | Wallace Dual Lumen Oocyte Recovery System | CooperSurgical, Inc. | 2019 | — |
| +3 | K191291 | Wallace Dual Lumen Oocyte Recovery System | CooperSurgical, Inc. | 2019 | — |
| +1 | K240523 | VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G)… | Shenzhen Vitavitro Biotech Co., Ltd. | 2024 | — |
| +4 | 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 |
|---|---|---|
| 2003 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2024 | 2 | 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? (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 |
|---|---|---|---|
| * | — | Ovum Pick-Up Aspiration Needles manufactured by Cook Australia Named without a submission number |
What descends from it? (8)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031622 | Wallace Dual Lumen Oocyte Retrieval Sets | 2003 | 3 |
| K240523 | VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double… | 2024 | 0 |
| K171625 | Single Lumen Ovum Aspiration Needles | 2018 | 0 |
| K171611 | Double Lumen Ovum Aspiration Needles | 2017 | 0 |
| K141365 | Otrieva Tapered Ovum Aspiration Needle Single Lumen | 2014 | 0 |
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?
- Of its descendants, K031622 (Portex, Ltd., 2003) has gone furthest, with 3 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 Ovum Pick-Up Aspiration Needles are used for aspiration and flushing of oocytes from 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/K983593 · printed Nov 5, 2026
Cite this page
510(k) Report. “K983593: Ovum Pick-UP Aspiration Needles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K983593
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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