K212731 is an FDA 510(k) clearance for the Circul8 Pro. This device is classified as a Sleeve, Limb, Compressible (Class II - Special Controls, product code JOW).
Submitted by Ortho8, Inc. (Rocklin, US). The FDA issued a Cleared decision on November 15, 2021, 77 days after receiving the submission on August 30, 2021.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5800.
| 510(k) Number | K212731 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 30, 2021 |
| Decision Date | November 15, 2021 |
| Days to Decision | 77 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | JOW - Sleeve, Limb, Compressible |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5800 |