Cleared Traditional

K260075 - eClinics

K260075 is an FDA 510(k) clearance for eClinics, manufactured by Ceiba Healthcare US, Inc.. The device is a Class 2 Cardiovascular device with product code MSX cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K260075 · Ceiba Healthcare US, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
268d
Days
Class 2
Risk

K260075 is an FDA 510(k) clearance for the eClinics. Classified as System, Network And Communication, Physiological Monitors (product code MSX), Class II - Special Controls.

Submitted by Ceiba Healthcare US, Inc. (New York, US). The FDA issued a Cleared decision on October 7, 2026 after a review of 268 days - an extended review cycle.

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.

FDA 510(k) Submission Details - K260075

510(k) Number K260075 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 2026
Decision Date October 07, 2026
Days to Decision 268 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
143d slower than avg
Panel avg: 125d · This submission: 268d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MSX Device Classification - Class 2, Special Controls

Product Code MSX System, Network And Communication, Physiological Monitors
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 - MSX System, Network And Communication, Physiological Monitors

All 119
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K260075 · eClinics
Download PDF FDA Summary Ceiba Healthcare US, …