Cardiomems, Inc.: FDA filings under this applicant name
FDA lists 4 510(k) clearances under the applicant name “Cardiomems, Inc.” (first 2006, latest 2008), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time under this name: 26 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NQH | Sensor, Pressure, Aneurysm, Implantable | 5 | 4 |
Review panels
- Cardiovascular (5)
Most recent Cardiomems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K082191 | CARDIOMEMS ENDOSURE S2 PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL S2-2080 | NQH | 2008-08-19 | 15 |
| K070680 | CARDIOMEMS ENDOSURE S2 14F WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL# S2-2080 | NQH | 2007-04-05 | 24 |
| K070448 | CARDIOMEMS ENDOSURE WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL ADS-1001 | NQH | 2007-03-15 | 28 |
| K061046 | CARDIOMEMS ENDOSURE PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL ADS-1001 AND INTERROGATOR, MODEL EMS 5001 | NQH | 2006-10-12 | 181 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN050006 | De Novo | Sensor, Pressure, Aneurysm, Implantable | 2005-10-28 |
Recalls
openFDA lists no recalls under a recalling firm named Cardiomems, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Cardiomems, Inc. is the lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT00531661: CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients (Completed, started 2007-09)
- NCT01162707: Wireless, Intermittent Monitoring of Right Heart Pressures in HF (Completed, started 2006-12)
Frequently asked questions
How many FDA 510(k) clearances are listed under Cardiomems, Inc.?
FDA lists 4 510(k) clearances under the applicant name “Cardiomems, Inc.” (first 2006, latest 2008), plus 1 De Novo decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Cardiomems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cardiomems, Inc. is 26 days.
Which FDA product codes appear under Cardiomems, Inc.?
The most frequent FDA product codes under this applicant name are NQH (Sensor, Pressure, Aneurysm, Implantable, 5).
Next steps
- See all 4 Cardiomems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NQH, Cardiomems, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.