De Novo · Granted
GrantedEarly Bird Bleed Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Saranas, Inc. · QFJ Intravascular Bleed Monitor
Granted on Mar 1, 2019 as a new device type through De Novo after a 312-day review. 1 later device descends from it.
- Decided
- Mar 1, 2019
- Review
- 312 days
- Class
- Class II
- Product code
- QFJ
- Recalls
- None
1 later device descends from it, 1 citing it directly.
- This deviceDEN180021 Early Bird Bleed Monitoring SystemSaranas, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK230273 Saranas Early Bird Bleed Monitoring SystemSaranas, Inc. · 2023
Most influential descendants
Showing 1 of 1 · See all- K230273Saranas Early Bird Bleed Monitoring SystemSaranas, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN180021 | Early Bird Bleed Monitoring System | Saranas, Inc. | 2019 | — |
| +1 | K230273 | Saranas Early Bird Bleed Monitoring System | Saranas, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QFJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QFJ device
- #1 K230273 Saranas Early Bird Bleed Monitoring Systemscore 5.4 · 1 generation · no Class I recall
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230273 | Saranas Early Bird Bleed Monitoring System | 2023 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K230273 (Saranas, Inc., 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All QFJ devicesQFJ Intravascular Bleed Monitor: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · QFJ
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · QFJ
Too few QFJ 510(k)s in any year since 2007 to give a median.
Recalls per year · QFJ
No recall names QFJ since 2007.
Adverse event reports per year · QFJ
3in 2023
MAUDE reports naming product code QFJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN180021 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN180021: Early Bird Bleed Monitoring System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN180021
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026