Cleared Special

Current Health System (K231506) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K231506 · Current Health , Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2023
Decision
92d
Days
Class 2
Risk

K231506 is an FDA 510(k) clearance for the Current Health System. Classified as System, Network And Communication, Physiological Monitors (product code MSX), Class II - Special Controls.

Submitted by Current Health , Ltd. (Edinburgh, GB). The FDA issued a Cleared decision on August 24, 2023 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Current Health , Ltd. devices

Submission Details

510(k) Number K231506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 2023
Decision Date August 24, 2023
Days to Decision 92 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 125d · This submission: 92d
Pathway characteristics
Modification to existing cleared device.

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 47
Devices cleared under the same product code (MSX) and FDA review panel - the closest regulatory comparables to K231506.
Infinity Gateway Suite
K233834 · Draeger Medical Systems, Inc. · Jul 2024
Biofourmis Everion+ (G2)
K233418 · Biofourmis Singapore Pte., Ltd. · May 2024
Corsano CardioWatch 287-2 System
K232548 · Corsano Health B.V. · Mar 2024
CNS-2101 Central Monitor
K223567 · Nihon Kohden Corporation · Jul 2023
Everion+ System
K213863 · Biofourmis Singapore Pte., Ltd. · Feb 2023
Current Health System
K222550 · Current Health , Ltd. · Nov 2022