510(k) · Cleared
ClearedSaranas Early 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
Cleared on May 25, 2023 as substantially equivalent to DEN180021 (Saranas, Inc., 2019) after a 114-day review. Its family tree reaches back 1 generation to 2019.
- Decided
- May 25, 2023
- Review
- 114 days
- Class
- Class II
- Product code
- QFJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN180021 (2019). No later device cites it as a predicate yet.
- Root · 1 generation backDEN180021 Early Bird Bleed Monitoring SystemSaranas, Inc. · 2019
- This deviceK230273 Saranas Early Bird Bleed Monitoring SystemSaranas, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN180021 | Early Bird Bleed Monitoring System | Saranas, Inc. | 2019 | — |
| 0 (this device) | K230273 | Saranas Early Bird Bleed Monitoring System | Saranas, Inc. | 2023 | — |
Sources: FDA 510(k) 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN180021 | Early Bird Bleed Monitoring SystemSummary page 4…lence Traditional 510(k) claiming equivalence to legally marketed device of same name: Saranas® Early Bird® Bleed Monitoring System DE NOVO Submission Number: DEN180021 Date DE NOVO Classification Granted: March 1, 2019 Device Description The Saranas Early Bird Bleed Monitoring System… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
How does its category compare?
All QFJ devicesQFJ Intravascular Bleed Monitor: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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/K230273 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230273: Saranas Early Bird Bleed Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230273
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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