Cleared Traditional

K210133 - Current Health Monitoring System Gen 2 (G2)

K210133 is an FDA 510(k) clearance for Current Health Monitoring System Gen 2 (G2), manufactured by Current Health. The device is a Class 2 Cardiovascular device with product code MSX cleared through the Traditional 510(k) pathway after a 227-day FDA review.

K210133 · Current Health · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2021
Decision
227d
Days
Class 2
Risk

K210133 is an FDA 510(k) clearance for the Current Health Monitoring System Gen 2 (G2). Classified as System, Network And Communication, Physiological Monitors (product code MSX), Class II - Special Controls.

Submitted by Current Health (Edinburgh, GB). The FDA issued a Cleared decision on September 3, 2021 after a review of 227 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 Current Health devices

FDA 510(k) Submission Details - K210133

510(k) Number K210133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 2021
Decision Date September 03, 2021
Days to Decision 227 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
102d slower than avg
Panel avg: 125d · This submission: 227d
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 73
Devices cleared under the same product code (MSX) and FDA review panel - the closest regulatory comparables to K210133.
Zyter RPM
K212622 · Zyter, Inc. · Feb 2022
AirStrip ONE Web Client with Alarm Communication Management (ACM)
K211949 · Airstrip Technologies, Inc. · Dec 2021
AlertWatch:AC
K210160 · Alertwatch, Inc. · Sep 2021
Smart Alarm Interface
K193421 · Boxview, LLC · Oct 2020
Aulisa Multiple Patient Digital Vital Sign Monitoring System
K202497 · Taiwan Aulisa Medical Devices Technologies, Inc. · Oct 2020
Spire Health Remote Patient Monitoring System
K192952 · Spire, Inc. D/B/A Spire Health · Jun 2020