Cleared Traditional

K254240 - Echo-2

K254240 is an FDA 510(k) clearance for Echo-2, manufactured by Neko Health AB. The device is a Class 2 Cardiovascular device with product code QOK cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K254240 · Neko Health AB · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Sep 2026
Decision
267d
Days
Class 2
Risk

K254240 is an FDA 510(k) clearance for the Echo-2. Classified as Hardware And Software For Optical Camera-based Measurement Of Heart Rate And Respiratory Rate (product code QOK), Class II - Special Controls.

Submitted by Neko Health AB (Danderyd, SE). The FDA issued a Cleared decision on September 22, 2026 after a review of 267 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2786 - 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 Neko Health AB devices

FDA 510(k) Submission Details - K254240

510(k) Number K254240 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2025
Decision Date September 22, 2026
Days to Decision 267 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
142d slower than avg
Panel avg: 125d · This submission: 267d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QOK Device Classification - Class 2, Special Controls

Product Code QOK Hardware And Software For Optical Camera-based Measurement Of Heart Rate And Respiratory Rate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2786
Definition The Device Uses An Optical Sensor System And Software Algorithms To Obtain And Analyze Video Signal And Estimate Pulse Rate, Heart Rate, Respiratory Rate And/or Breathing Rates. This Device Is Not Intended To Independently Direct Therapy.
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

Healthcare Innovation Catalysts, Inc.
Brittany Valdez Nava

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.