Circul8 Pro
FDA 510(k) clearance K212731 · decided 2021-11-15
Clearance details
- K-number
- K212731
- Device name
- Circul8 Pro
- Applicant
- Ortho8, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-08-30
- Decision date
- 2021-11-15
- Days to decision
- 77 days
- Clearance type
- Special
- Product code
- JOW
- Device class
- 2
- Regulation number
- 870.5800
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Rocklin, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Ortho8
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.