K250922 is an FDA 510(k) clearance for the Edema Guard Monitor (EGM) CardioSet-001. This device is classified as a Plethysmograph, Impedance (Class II - Special Controls, product code DSB).
Submitted by Cardioset Medical , Ltd. (Matan, IL). The FDA issued a Cleared decision on September 9, 2025, 166 days after receiving the submission on March 27, 2025.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2770.
| 510(k) Number | K250922 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 27, 2025 |
| Decision Date | September 09, 2025 |
| Days to Decision | 166 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DSB - Plethysmograph, Impedance |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2770 |