Cardiocomm Solutions, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Cardiocomm Solutions, Inc.” (first 2002, latest 2019), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 114 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 | 1 | 44 |
| 2013 | 0 | — |
| 2014 | 1 | 531 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 281 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Cardiocomm Solutions, Inc. took a median 281 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 210 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DPS | Electrocardiograph | 4 | 4 |
| DSH | Recorder, Magnetic Tape, Medical | 4 | 4 |
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 1 | 1 |
Review panels
- Cardiovascular (9)
Most recent Cardiocomm Solutions, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K181310 | HeartCheck Cardi Beat ECG Monitor with GEMS Mobile | DXH | 2019-02-22 | 281 |
| K122632 | GUAVA II | DPS | 2014-02-11 | 531 |
| K121009 | HEARTCHECK ECG PEN WITH GEMS HOME | DPS | 2012-05-17 | 44 |
| K111159 | HEARTCHECK PEN HANDHELD ECG WITH GEMS HOME | DPS | 2011-12-22 | 241 |
| K111320 | GLOBALCARDIO | DSH | 2011-10-07 | 150 |
| K033037 | MODIFICATION TO GLOBALCARDIO | DSH | 2003-10-31 | 32 |
| K022297 | GLOBAL ECG MANAGEMENT SYSTEM (GEMS) | DSH | 2002-09-27 | 73 |
| K020366 | GLOBAL ECG MANAGEMENT SYSTEM (GEMS) | DPS | 2002-04-30 | 85 |
| K013354 | GLOBALCARDIO | DSH | 2002-01-31 | 114 |
Recalls
openFDA lists no recalls under a recalling firm named Cardiocomm Solutions, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Cardiocomm Solutions, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Cardiocomm Solutions, Inc.” (first 2002, latest 2019), across 3 product codes 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 Cardiocomm Solutions, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cardiocomm Solutions, Inc. is 114 days.
Which FDA product codes appear under Cardiocomm Solutions, Inc.?
The most frequent FDA product codes under this applicant name are DPS (Electrocardiograph, 4); DSH (Recorder, Magnetic Tape, Medical, 4); DXH (Transmitters And Receivers, Electrocardiograph, Telephone, 1).
Next steps
- See all 9 Cardiocomm Solutions, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DPS, Cardiocomm Solutions, 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.