Cleared Traditional

K262816 - EXG PulseLinQ Cables (EXGPL)

K262816 is an FDA 510(k) clearance for EXG PulseLinQ Cables (EXGPL), manufactured by Cb Innovations, LLC. The device is a Class 2 Cardiovascular device with product code DSA cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K262816 · Cb Innovations, LLC · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
84d
Days
Class 2
Risk

K262816 is an FDA 510(k) clearance for the EXG PulseLinQ Cables (EXGPL). Classified as Cable, Transducer And Electrode, Patient, (including Connector) (product code DSA), Class II - Special Controls.

Submitted by Cb Innovations, LLC (Carlsbad, US). The FDA issued a Cleared decision on October 30, 2026 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2900 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K262816

510(k) Number K262816 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2026
Decision Date October 30, 2026
Days to Decision 84 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
41d faster than avg
Panel avg: 125d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSA Device Classification - Class 2, Special Controls

Product Code DSA Cable, Transducer And Electrode, Patient, (including Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2900
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 Peers - DSA Cable, Transducer And Electrode, Patient, (including Connector)

All 101
Devices cleared under the same product code (DSA) and FDA review panel - the closest regulatory comparables to K262816.
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K240087 · Ivy Biomedical Systems, Inc. · Sep 2024
K262816 · EXG PulseLinQ Cables (EXGPL)
Download PDF FDA Summary Cb Innovations, LLC