Cleared Abbreviated

K050858 - ASCENTIA HEARTSTATION ECG MANAGEMENT SYSTEM

K050858 is an FDA 510(k) clearance for ASCENTIA HEARTSTATION ECG MANAGEMENT SYSTEM, manufactured by Heartlab, Inc.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Abbreviated 510(k) pathway after a 85-day FDA review.

K050858 · Heartlab, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2005
Decision
85d
Days
Class 2
Risk

K050858 is an FDA 510(k) clearance for the ASCENTIA HEARTSTATION ECG MANAGEMENT SYSTEM. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Heartlab, Inc. (Westerly, US). The FDA issued a Cleared decision on June 29, 2005 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - the FDA cardiovascular device oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Heartlab, Inc. devices

FDA 510(k) Submission Details - K050858

510(k) Number K050858 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2005
Decision Date June 29, 2005
Days to Decision 85 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 125d · This submission: 85d
Pathway characteristics
Standards-based clearance path.

DPS Device Classification - Class 2, Special Controls

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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 - DPS Electrocardiograph

All 362
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K050858.
PORTABLE, ELECTROCARDIOGRAPH (ECG) MONITOR, MODEL HCG-801
K060766 · Omron Healthcare, Inc. · Jun 2006
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K052511 · Nihon Kohden America, Inc. · May 2006
PHILIPS 12-LEAD ALGORITHM
K052049 · Philips Medical Systems · Aug 2005
CARDIOVIT AT-10PLUS
K050686 · Schiller AG · May 2005
12-LEAD RESTING ELECTROCARDIOGRAPH, MODELS CP100 & CP200
K050074 · Welch Allyn, Inc. · Mar 2005
CARDIOFAX CE, MODEL PEA-1110K
K042827 · Nihon Kohden America, Inc. · Jan 2005