Cleared Traditional

K240558 - NAVOYCDS (FDA 510(k) Clearance)

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

K240558 · Algodx AB · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jul 2024
Decision
145d
Days
Class 2
Risk

K240558 is an FDA 510(k) clearance for the NAVOYCDS. Classified as Multivariate Vital Signs Index (product code PLB), Class II - Special Controls.

Submitted by Algodx AB (Stockholm, SE). The FDA issued a Cleared decision on July 22, 2024 after a review of 145 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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 Algodx AB devices

Submission Details

510(k) Number K240558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2024
Decision Date July 22, 2024
Days to Decision 145 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 125d · This submission: 145d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PLB Multivariate Vital Signs Index
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
Definition Automated Calculation Of A Summary Index (or Indices) Based On Several Individual Measured Vital Sign Inputs.
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.