Tempus ECG-AF
FDA 510(k) clearance K233549 · decided 2024-06-21
Clearance details
- K-number
- K233549
- Device name
- Tempus ECG-AF
- Applicant
- Tempus AI, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-11-03
- Decision date
- 2024-06-21
- Days to decision
- 231 days
- Clearance type
- Traditional
- Product code
- SBQ
- Device class
- 2
- Regulation number
- 870.2380
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Chicago, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Tempus AI
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.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| xT CDx (P210011/S003) | Tempus AI, Inc. | 2025-06-27 |
| xT CDx (P210011/S001) | Tempus AI, Inc. | 2023-06-07 |
| xT CDx (P210011) | Tempus AI, Inc. | 2023-04-28 |