# K230273: Saranas Early Bird Bleed Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Saranas, Inc.
- Decided: May 25, 2023 after 114 days
- Product code: QFJ (Intravascular Bleed Monitor)
- Device class: 2
- Regulation: 21 CFR 870.1345
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN180021 (2019). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN180021: Early Bird Bleed Monitoring System, Saranas, Inc. (2019) Summary page 4.

## Indications for use
The Early Bird is indicated for the introduction of catheters, catheter balloons, and other diagnostic and interventional devices into the femoral artery or femoral vein while maintaining hemostasis during diagnostic and interventional endovascular procedures. The Early Bird provides physicians with an early indication of a potential internal bleeding complication by initial detection and monitoring of extravascular fluid accumulation.

Source page: https://510kreport.com/device/K230273
Methodology: https://510kreport.com/methodology