Cleared Traditional

K153275 - Aingeal Activity System

K153275 is an FDA 510(k) clearance for Aingeal Activity System, manufactured by Intelesens, Ltd.. The device is a Class 2 Cardiovascular device with product code MHX cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K153275 · Intelesens, Ltd. · Cardiovascular device
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Feb 2016
Decision
106d
Days
Class 2
Risk

K153275 is an FDA 510(k) clearance for the Aingeal Activity System. Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by Intelesens, Ltd. (Belfast, GB). The FDA issued a Cleared decision on February 26, 2016 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - 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 Intelesens, Ltd. devices

FDA 510(k) Submission Details - K153275

510(k) Number K153275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2015
Decision Date February 26, 2016
Days to Decision 106 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
19d faster than avg
Panel avg: 125d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MHX Device Classification - Class 2, Special Controls

Product Code MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
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 - MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

All 334
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K153275.
Patient Monitor
K152552 · Edan Instruments, Inc. · Apr 2016
AVIVO Mobile Patient Management (MPM) System
K153160 · Medtronic, Inc. · Mar 2016
Passport Series Patient Monitors (Including Passport 8, Passport 12)
K153448 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Mar 2016
Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)
K152902 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Feb 2016
PATIENT MONITORS VARIOUS MODELS
K151812 · Philips Medical Systems · Jan 2016
Panorama Patient Monitoring Network
K150082 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Sep 2015