Saranas Early Bird Bleed Monitoring System
FDA 510(k) clearance K230273 · decided 2023-05-25
Clearance details
- K-number
- K230273
- Device name
- Saranas Early Bird Bleed Monitoring System
- Applicant
- Saranas, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-01-31
- Decision date
- 2023-05-25
- Days to decision
- 114 days
- Clearance type
- Traditional
- Product code
- QFJ
- Device class
- 2
- Regulation number
- 870.1345
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Houston, TX, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Saranas
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
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.
| Record | Firm | Date |
|---|---|---|
| Early Bird Bleed Monitoring System (DEN180021) | Saranas, Inc. | 2019-03-01 |
Recalls involving this device
No recalls on record reference this clearance.