Cleared Traditional

K230273 - Saranas Early Bird Bleed Monitoring System (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K230273 · Saranas, Inc. · Cardiovascular device
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May 2023
Decision
114d
Days
Class 2
Risk

K230273 is an FDA 510(k) clearance for the Saranas 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 Cleared decision on May 25, 2023 after a review of 114 days - within the typical 510(k) review window.

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 establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Saranas, Inc. devices

Submission Details

510(k) Number K230273 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2023
Decision Date May 25, 2023
Days to Decision 114 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 125d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.

Regulatory Consultant

RQM+
Allison Komiyama

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.