510(k) · Cleared
ClearedCardiomems Endosure Pressure Sensor with Delivery System, Model Ads-1001 and Interrogator, Model Ems 5001
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiomems, Inc. · NQH Sensor, Pressure, Aneurysm, Implantable
Cleared on Oct 12, 2006 after a 181-day review. The FDA summary names its predicate without a number.
- Decided
- Oct 12, 2006
- Review
- 181 days
- Class
- Class II
- Product code
- NQH
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 NQH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | — | CardioMEMS EndoSureTM Wireless AAA Pressure Measurement System Named without a submission number |
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 NQH devicesNQH Sensor, Pressure, Aneurysm, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NQH
1in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · NQH
Too few NQH 510(k)s in any year since 2007 to give a median.
Recalls per year · NQH
No recall names NQH since 2007.
Adverse event reports per year · NQH
2in 2009
MAUDE reports naming product code NQH, 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 | 2 | — | 0 | 17 |
| 2008 | 1 | — | 0 | 8 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The CardioMEMS EndoSure Wireless AAA Pressure Measurement System is intended
for measuring intrasac pressure during endovascular abdominal aortic aneurysm (AAA)
repair. It may be used as an adjunctive tool in the detection of intraoperative endoleaks.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061046 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061046: Cardiomems Endosure Pressure Sensor with Delivery System, Model Ads-1001 and Interrogator, Model Ems 5001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061046
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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