Cleared Traditional

K150117 - Medtronic Patient Asistant

K150117 is an FDA 510(k) clearance for Medtronic Patient Asistant, manufactured by Medtronic, Inc.. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K150117 · Medtronic, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2015
Decision
127d
Days
Class 2
Risk

K150117 is an FDA 510(k) clearance for the Medtronic Patient Asistant. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Medtronic, Inc. (Mounds View, US). The FDA issued a Cleared decision on May 27, 2015 after a review of 127 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.

FDA 510(k) Submission Details - K150117

510(k) Number K150117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 2015
Decision Date May 27, 2015
Days to Decision 127 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
2d slower than avg
Panel avg: 125d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSI Device Classification - Class 2, Special Controls

Product Code DSI Detector And Alarm, Arrhythmia
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 - DSI Detector And Alarm, Arrhythmia

All 336
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K150117.
BodyGuardian Remote Monitoring System
K151188 · Preventice · Sep 2015
CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector
K143359 · Lifewatch Technologies , Ltd. · Sep 2015
IntelliVue Patient Monitor
K151681 · Philips Medizin Systeme Boeblingen GmbH · Jul 2015
IntelliVue Patient Monitor
K150310 · Philips Medizin Systeme Boeblingen GmbH · May 2015
CardiacLinx
K142352 · Ross Medical Technology, Inc. · Mar 2015
MENNTOR X7
K141441 · Mennen Medical , Ltd. · Jan 2015
K150117 · Medtronic Patient Asistant
Download PDF FDA Summary Medtronic, Inc.