Kardium, Inc.: FDA filings under this applicant name
FDA lists 2 510(k) clearances under the applicant name “Kardium, Inc.” (first 2025, latest 2025), plus 1 PMA decision, across 3 product codes in 1 review panel. Median 510(k) review time under this name: 102 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 |
|---|---|---|
| 2025 | 2 | 102 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Kardium, Inc. took a median 102 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 118 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQK | Computer, Diagnostic, Programmable | 1 | 1 |
| DRA | Catheter, Steerable | 1 | 1 |
| QZI | Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation | 1 | 0 |
Review panels
- Cardiovascular (3)
Most recent Kardium, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250747 | Globe® Pulsed Field System | DQK | 2025-06-25 | 105 |
| K250529 | Globe Introducer (601-01001) | DRA | 2025-06-03 | 99 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P240044 | PMA | Globe® Pulsed Field System | 2025-08-27 |
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2012-08-28.
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 Kardium, Inc. is the lead sponsor of 6 device studies on ClinicalTrials.gov (3 active or recruiting). Most recent:
- NCT06973031: A Prospective Clinical Study to Evaluate the Safety and Effectiveness of Pulmonary Vein Isolation Plus Box Isolation of Fibrotic Areas With the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal or Persistent Atrial Fibrillation (Recruiting, started 2025-06-10)
- NCT05462145: Safety and Effectiveness of the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal or Persistent Atrial Fibrillation (Active not recruiting, started 2023-03-09)
- NCT05164107: Safety and Performance of a Pulsed Field Device for Global Mapping and Ablation of the Left Atrium for the Treatment of Atrial Fibrillation (Recruiting, started 2021-12-08)
- NCT04486924: Performance and Safety of the Globe® Mapping and Ablation System With the GPS™ Module for the Treatment of Atrial Fibrillation (Completed, started 2021-04-05)
- NCT02168972: Safety and Performance of a GLOBAL Mapping and Ablation Device for the Treatment of Atrial Fibrillation (GLOBAL-AF) (Completed, started 2014-11)
Frequently asked questions
How many FDA 510(k) clearances are listed under Kardium, Inc.?
FDA lists 2 510(k) clearances under the applicant name “Kardium, Inc.” (first 2025, latest 2025), plus 1 PMA decision, 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 Kardium, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Kardium, Inc. is 102 days.
Which FDA product codes appear under Kardium, Inc.?
The most frequent FDA product codes under this applicant name are DQK (Computer, Diagnostic, Programmable, 1); DRA (Catheter, Steerable, 1); QZI (Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation, 1).
Next steps
- See all 2 Kardium, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DQK, Kardium, 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.