Not Cleared Direct

DEN180021 - Early Bird Bleed Monitoring System (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN180021 · Saranas, Inc. · Cardiovascular device
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Mar 2019
Decision
312d
Days
Class 2
Risk

DEN180021 is an FDA 510(k) submission (not cleared) for the Early Bird Bleed Monitoring System. Classified as Intravascular Bleed Monitor (product code QFJ), Class II - Special Controls.

Submitted by Saranas, Inc. (Houston, US). The FDA issued a Not Cleared (DENG) decision on March 1, 2019 after a review of 312 days.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1345 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 312 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Saranas, Inc. devices

Submission Details

510(k) Number DEN180021 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received April 23, 2018
Decision Date March 01, 2019
Days to Decision 312 days
Submission Type Direct
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
187d slower than avg
Panel avg: 125d · This submission: 312d
Pathway characteristics

Device Classification

Product Code QFJ Intravascular Bleed Monitor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1345
Definition An Intravascular Bleed Monitor Is A Probe, Catheter, Or Catheter Introducer That Measures Changes In Bioimpedance And Uses An Algorithm To Detect Or Monitor Progression Of Potential Internal Bleeding Complications.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.