Cleared Traditional

K240794 - Frontier X Plus

K240794 is an FDA 510(k) clearance for Frontier X Plus, manufactured by Fourth Frontier Technologies Pvt, Ltd.. The device is a Class 2 Cardiovascular device with product code MLO cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K240794 · Fourth Frontier Technologies Pvt, Ltd. · Cardiovascular device
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Nov 2024
Decision
231d
Days
Class 2
Risk

K240794 is an FDA 510(k) clearance for the Frontier X Plus. Classified as Electrocardiograph, Ambulatory, With Analysis Algorithm (product code MLO), Class II - Special Controls.

Submitted by Fourth Frontier Technologies Pvt, Ltd. (Bengaluru, IN). The FDA issued a Cleared decision on November 8, 2024 after a review of 231 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2800 - 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 Fourth Frontier Technologies Pvt, Ltd. devices

FDA 510(k) Submission Details - K240794

510(k) Number K240794 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2024
Decision Date November 08, 2024
Days to Decision 231 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
106d slower than avg
Panel avg: 125d · This submission: 231d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MLO Device Classification - Class 2, Special Controls

Product Code MLO Electrocardiograph, Ambulatory, With Analysis Algorithm
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2800
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 - MLO Electrocardiograph, Ambulatory, With Analysis Algorithm

All 7
Devices cleared under the same product code (MLO) and FDA review panel - the closest regulatory comparables to K240794.
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