510(k) · Cleared
ClearedWallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC); Wallace® Vacuum Connection Kit (WVCK)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
CooperSurgical, Inc. · MQG Accessory, Assisted Reproduction
Cleared on Aug 19, 2026 as substantially equivalent to K160753 (William A. Cook Australia Pty., Ltd., 2017) after a 140-day review. Its family tree reaches back 2 generations to 1999.
- Decided
- Aug 19, 2026
- Review
- 140 days
- Class
- Class II
- Product code
- MQG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K992070 (1999). No later device cites it as a predicate yet.
- Root · 2 generations backK992070 Cook Ultra Quiet Vacuum Pump & RegulatorCook Urological, Inc. · 1999 · Recalled
- 1 generation backK160753 COOK Vacuum PumpWilliam A. Cook Australia Pty., Ltd. · 2017 · Recalled
- This deviceK261083 Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector…CooperSurgical, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K992070 | Cook Ultra Quiet Vacuum Pump & Regulator | Cook Urological, Inc. | 1999 | 2 |
| −1 | K160753 | COOK Vacuum Pump | William A. Cook Australia Pty., Ltd. | 2017 | 1 |
| 0 (this device) | K261083 | Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC)… | CooperSurgical, Inc. | 2026 | — |
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 MQG? 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 MQG device
- #1 K260194 Vacuum Pump (Model: AD-VPUM-500)score 11.5 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K160753 | COOK Vacuum PumpSummary page 5…egulation Name: Assisted Reproduction Accessories Regulatory Class: II Product Code: MQG (Accessory, Assisted Reproduction) 4. Predicative Device Submission Number: K160753 Device Trade Name: COOK Vacuum Pump The predicate device has not been subject to a design-related recall. 5. Device Descripti… | 2017 |
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.
What does this lineage say?
- The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 17.6 years on median.
- 2 of the 2 ancestors have a recall of any class.
- 1 other device also cites its predicate K160753.
How does its category compare?
All MQG devicesMQG Accessory, Assisted Reproduction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · MQG
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQG
135in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQG
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQG
1in 2025
MAUDE reports naming product code MQG, 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 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 4 | 137 | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 3 | 236 | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 1 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 3 | 135 | 0 | 0 |
| 2019 | 0 | — | 1 | 2 |
| 2020 | 0 | — | 1 | 3 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 1 | 3 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC); Wallace® Vacuum Connection Kit (WVCK) is intended for the aspiration of oocytes during assisted reproduction procedures using low flow, intermittent vacuum.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261083 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261083: Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC); Wallace® Vacuum Connection Kit (WVCK).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261083
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026