Cardiodynamics International Corp.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Cardiodynamics International Corp.” (first 1996, latest 2009), across 1 product code in 1 review panel. Median 510(k) review time under this name: 87 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 |
|---|---|---|---|
| DSB | Plethysmograph, Impedance | 11 | 11 |
Review panels
- Cardiovascular (11)
Most recent Cardiodynamics International Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K090602 | CARDIODYNAMICS BIOZ RX, MODEL 7101-SYS | DSB | 2009-05-28 | 84 |
| K070156 | BIOZ DX HEMODYNAMIC MONITOR WITH PHILIPS 12-LEAD ECG, MODEL 5100 | DSB | 2007-09-26 | 252 |
| K051228 | BIOZDX HEMODYNAMIC MONITOR AND 12-LEAD ECG | DSB | 2005-06-10 | 28 |
| K041294 | BIOZDX HEMODYNAMIC MONITOR | DSB | 2004-12-08 | 208 |
| K011439 | MODIFICATION TO BIOZ.COM HEMODYNAMIC MONITOR | DSB | 2001-11-02 | 176 |
| K011797 | BIOZTECT SENSOR AND BIOZTECT CABLE | DSB | 2001-07-03 | 25 |
| K001081 | BIOZ.PC HEMODYNAMIC MONITOR MODEL BZ-500/BZ-501; BIOZ.PC USER SOFTWARE INSTALLATION KIT MODEL BZ-810 | DSB | 2000-06-30 | 87 |
| K001100 | BIOZ.COM HEMODYNAMIC MONITOR WITH BIOZ TECT SENSOR AND BIOZ TECT CABLE IMPEDANCE PLETHYSMOGRAPH | DSB | 2000-05-05 | 30 |
| K974725 | BIOZ.COM SYSTEM | DSB | 1998-03-18 | 90 |
| K972320 | BIOZ SYSTEM & BIOZ PORTABLE | DSB | 1997-09-11 | 80 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Cardiodynamics International Corp..
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 Cardiodynamics International Corp.?
FDA lists 11 510(k) clearances under the applicant name “Cardiodynamics International Corp.” (first 1996, latest 2009), 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 Cardiodynamics International Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cardiodynamics International Corp. is 87 days.
Which FDA product codes appear under Cardiodynamics International Corp.?
The most frequent FDA product codes under this applicant name are DSB (Plethysmograph, Impedance, 11).
Next steps
- See all 11 Cardiodynamics International Corp. clearances with predicates and recalls
- Run predicate analysis for product code DSB, Cardiodynamics International Corp.'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.