Cleared Traditional

K024278 - PACEART SYSTEM

K024278 is an FDA 510(k) clearance for PACEART SYSTEM, manufactured by Medtronic Vascular. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K024278 · Medtronic Vascular · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2003
Decision
157d
Days
Class 2
Risk

K024278 is an FDA 510(k) clearance for the PACEART SYSTEM. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on May 29, 2003 after a review of 157 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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 Medtronic Vascular devices

FDA 510(k) Submission Details - K024278

510(k) Number K024278 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2002
Decision Date May 29, 2003
Days to Decision 157 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
32d slower than avg
Panel avg: 125d · This submission: 157d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 418
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K024278.
CARDIOVIT AT-102
K031557 · Schiller AG · Apr 2004
ELI 200+ AUDICOR
K031182 · Mortara Instrument, Inc. · Jul 2003
PHILIPS PAGE WRITER TRIM SERIES CARDIOGRAPH INCLUDING I, II, III, MODELS 860286, 860287, 860288, 860289, 860290, 860291
K031422 · Philips Medical Systems · Jul 2003
X-SCRIBE II
K022618 · Mortara Instrument, Inc. · Sep 2002
CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000
K022149 · Cambridge Heart, Inc. · Jul 2002
HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS
K022152 · Cambridge Heart, Inc. · Jul 2002