Cleared Traditional

K150289 - CARDIOLINE HD+

K150289 is an FDA 510(k) clearance for CARDIOLINE HD+, manufactured by Cardioline S.P.A. The device is a Class 2 Cardiovascular device with product code DRG cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K150289 · Cardioline S.P.A · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2015
Decision
203d
Days
Class 2
Risk

K150289 is an FDA 510(k) clearance for the CARDIOLINE HD+. Classified as Transmitters And Receivers, Physiological Signal, Radiofrequency (product code DRG), Class II - Special Controls.

Submitted by Cardioline S.P.A (Cavareno, US). The FDA issued a Cleared decision on August 27, 2015 after a review of 203 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2910 - 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 Cardioline S.P.A devices

FDA 510(k) Submission Details - K150289

510(k) Number K150289 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2015
Decision Date August 27, 2015
Days to Decision 203 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
78d slower than avg
Panel avg: 125d · This submission: 203d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRG Device Classification - Class 2, Special Controls

Product Code DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2910
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 - DRG Transmitters And Receivers, Physiological Signal, Radiofrequency

All 74
Devices cleared under the same product code (DRG) and FDA review panel - the closest regulatory comparables to K150289.
Patient Status Engine
K172329 · Isansys Lifecare, Ltd. · Apr 2018
FFR Link, FFR Signal Processing Module
K170204 · Boston Scientific Corporation · Mar 2017
TelePatch Cardiac Monitor
K161916 · Medicomp, Inc. · Dec 2016
SURVEYOR S4 MOBILE MONITOR
K141020 · Mortara Instrument, Inc. · Dec 2014
S HEALTH
K132148 · Samsung Electronics Co., Ltd. · Dec 2013
INTELLIVUE CL SPO2 POD AND CL NBP POD, PHILIPS INTELLIVUE PATIENT MONITORS MP5, MP5T, MP5SC
K131913 · Philips Medizin Systeme Boeblingen GmbH · Nov 2013