# DEN180021: Early Bird Bleed Monitoring System

- Pathway: De Novo (Direct)
- Applicant: Saranas, Inc.
- Decided: Mar 1, 2019 after 312 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K230273: Saranas Early Bird Bleed Monitoring System (2023), 0 descendants of its own

## 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/DEN180021
Methodology: https://510kreport.com/methodology