510(k) · Cleared
Recalled · Class II · 2018Cook Ultra Quiet Vacuum Pump & Regulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Urological, Inc. · MQG Accessory, Assisted Reproduction
Cleared on Oct 27, 1999 after a 131-day review. The FDA summary names its predicate without a number. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Oct 27, 1999
- Review
- 131 days
- Class
- Class II
- Product code
- MQG
- Recalls
- 2
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK992070 Cook Ultra Quiet Vacuum Pump & RegulatorCook Urological, Inc. · 1999
- Descendant · cites it directly · 2 of its ownK160753 COOK Vacuum PumpWilliam A. Cook Australia Pty., Ltd. · 2017 · Recalled
- Descendant · 2 generations on · 0 of its ownK261083 Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector…CooperSurgical, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK260194 Vacuum Pump (Model: AD-VPUM-500)Sheng Sheng Yi (Beijing) Technology Company Limited · 2026
Most influential descendants
Showing 3 of 3 · See all- K160753COOK Vacuum PumpWilliam A. Cook Australia Pty., Ltd. · 2017 · cites it directly2descendants
- K261083Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC); Wallace® Vacuum…CooperSurgical, Inc. · 2026 · 2 generations on0descendants
- K260194Vacuum Pump (Model: AD-VPUM-500)Sheng Sheng Yi (Beijing) Technology Company Limited · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K992070 | Cook Ultra Quiet Vacuum Pump & Regulator | Cook Urological, Inc. | 1999 | — |
| +1 | K160753 | COOK Vacuum Pump | William A. Cook Australia Pty., Ltd. | 2017 | 1 |
| +2 | K261083 | Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC)… | CooperSurgical, Inc. | 2026 | — |
| +2 | K260194 | Vacuum Pump (Model: AD-VPUM-500) | Sheng Sheng Yi (Beijing) Technology Company Limited | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2026 | 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 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 K261083 Wallace® Aspiration Pump (WAPV1); Wallace®…score 12.2 · 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 |
|---|---|---|---|
| * | — | Published predicate device description (63 FR 48428, September 10, 1998) Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160753 | COOK Vacuum Pump | 2017 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 22, 2018 | Class II | Z-1461-2018 | Nonconforming Material/Component | Pump was found to be constructed from crimp connectors that do not meet the fixation wiring requirements and can cause failure of the device to operate or electric shock or burn to the user. |
| Mar 22, 2018 | Class II | Z-1460-2018 | Nonconforming Material/Component | Pump was found to be constructed from crimp connectors that do not meet the fixation wiring requirements and can cause failure of the device to operate or electric shock or burn to the user. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K160753 (William A. Cook Australia Pty., Ltd., 2017) has gone furthest, with 2 descendants of its own.
How does its category compare?
All MQG devicesMQG Accessory, Assisted Reproduction: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 COOK® Ultra Quiet Vacuum Pump & Regulator is intended for the aspiration of eggs (ova), during assisted reproduction procedures using low flow, intermittent vacuum.
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/K992070 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992070: Cook Ultra Quiet Vacuum Pump & Regulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992070
Report an extraction error
Are you the manufacturer?
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