Saranas Early Bird Bleed Monitoring System is an AI-enabled medical device from Saranas Inc. that the U.S. FDA cleared through 510(k) K230273 on May 25, 2023. Its lead review panel is Cardiovascular and its primary product code is QFJ (Intravascular Bleed Monitor).
See also FDA-cleared AI cardiovascular devices in 2023, all FDA AI clearances in 2023, top cardiovascular AI devices.
Key facts
| Submission number | K230273 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | Saranas Inc. |
| Lead review panel | Cardiovascular |
| Primary product code | QFJ — Intravascular Bleed Monitor |
| Applicant (openFDA) | Saranas, Inc. |
| Applicant location | Houston, TX, US |
| Device class | Class 2 |
| Regulation number | 21 CFR 870.1345 |
| Decision code | SESE |
| Submission type | Traditional |
Source: FDA AI-Enabled Medical Devices list and openFDA.
What this means
A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. Saranas Early Bird Bleed Monitoring System went through this pathway (K230273).
openFDA lists it as a Class 2 device under 21 CFR 870.1345. Class II devices are moderate risk and are subject to general and special controls.
Product code QFJ covers 1 device on the FDA AI list. By decision date, this device is #1 of 1 under that code. Saranas Inc. has 1 AI-enabled device on the list, and the Cardiovascular panel accounts for 154 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.