Cleared Traditional

Biofourmis Everion+ (G2) (K233418) - FDA 510(k) Clearance

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

K233418 · Biofourmis Singapore Pte., Ltd. · Cardiovascular device
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May 2024
Decision
212d
Days
Class 2
Risk

K233418 is an FDA 510(k) clearance for the Biofourmis Everion+ (G2). Classified as System, Network And Communication, Physiological Monitors (product code MSX), Class II - Special Controls.

Submitted by Biofourmis Singapore Pte., Ltd. (Singapore, SG). The FDA issued a Cleared decision on May 9, 2024 after a review of 212 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.

View all Biofourmis Singapore Pte., Ltd. devices

Submission Details

510(k) Number K233418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 2023
Decision Date May 09, 2024
Days to Decision 212 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
87d slower than avg
Panel avg: 125d · This submission: 212d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 44
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