Cleared Traditional

K221260 - CSF-3 (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence.

K221260 · Cardiacsense · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2023
Decision
249d
Days
Class 2
Risk

K221260 is an FDA 510(k) clearance for the CSF-3. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Cardiacsense (Caesarea, IL). The FDA issued a Cleared decision on January 6, 2023 after a review of 249 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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 Cardiacsense devices

Submission Details

510(k) Number K221260 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2022
Decision Date January 06, 2023
Days to Decision 249 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
124d slower than avg
Panel avg: 125d · This submission: 249d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Regulatory Consultant

RQM+
Oxana S. Pantchenko

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.

Clinical Evidence

ClinicalTrials.gov
NCT05322382 Completed Interventional Industry-sponsored

Accuracy of Pulse Oximeters With Profound Hypoxia

Accuracy of Pulse Oximeters With Profound Hypoxia - Test Protocol

12
Patients (actual)
1
Site
Other
Purpose
Open label
Masking
Condition studied SpO2
Study design Single group
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Principal investigator Philip Bickler, MD
Sponsor CardiacSense Ltd. (industry)
Started 2021-06-02 → Primary completion 2021-06-03
Primary outcome
Accuracy of pulse oximeter with profound hypoxia
Study completed - no results published. This trial concluded in 2021 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished. Individual participant data will not be shared.
View full study on ClinicalTrials.gov

Regulatory Peers - DPS Electrocardiograph

All 574
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