K220527 is an FDA 510(k) clearance for the PADnet Xpress. This device is classified as a Plethysmograph, Photoelectric, Pneumatic Or Hydraulic (Class II - Special Controls, product code JOM).
Submitted by Collaborative Care Diagnostics, LLC, D.B.A. Biomedix (Eagan, US). The FDA issued a Cleared decision on October 20, 2022, 238 days after receiving the submission on February 24, 2022.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2780.
| 510(k) Number | K220527 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 24, 2022 |
| Decision Date | October 20, 2022 |
| Days to Decision | 238 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | JOM — Plethysmograph, Photoelectric, Pneumatic Or Hydraulic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2780 |