Cleared Traditional

K221260 - CSF-3

K221260 is an FDA 510(k) clearance for CSF-3, manufactured by Cardiacsense. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 249-day FDA review.

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

FDA 510(k) Submission Details - K221260

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.

DPS Device Classification - Class 2, Special Controls

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 283
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K221260.
Electrocardiograph: SE-1200 Pro and SE-1201 Pro
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AccurECG Analysis System
K223013 · Accurkardia, Inc. · Jun 2023
PageWriter TC35 Cardiograph
K221141 · Medizin Systeme Boblingen GmbH · Dec 2022
Cardio10
K220535 · Bionet Co., Ltd. · Nov 2022
MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System
K221321 · Ge Medical Systems Information Technologies, Inc. · Oct 2022