Cleared Abbreviated

K010587 - ACTIVEECG

K010587 is an FDA 510(k) clearance for ACTIVEECG, manufactured by Active Corp.. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Abbreviated 510(k) pathway after a 78-day FDA review.

K010587 · Active Corp. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
78d
Days
Class 2
Risk

K010587 is an FDA 510(k) clearance for the ACTIVEECG. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Active Corp. (Castine, US). The FDA issued a Cleared decision on May 16, 2001 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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.

FDA 510(k) Submission Details - K010587

510(k) Number K010587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2001
Decision Date May 16, 2001
Days to Decision 78 days
Submission Type Abbreviated
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
47d faster than avg
Panel avg: 125d · This submission: 78d
Pathway characteristics
Standards-based clearance path.

DRT Device Classification - Class 2, Special Controls

Product Code DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 - DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

All 324
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K010587.
SIEMENS INFINITY SC 6002XL MODIFICATIONS
K020144 · Siemens Medical Solutions USA, Inc. · Feb 2002
SORIN BIOMEDICA SMART BCD VANGUARD,SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM
K012763 · Cobe Cardiovascular, Inc. · Nov 2001
PROPAQ ENCORE MODELS 202, 204, 206
K012451 · Welch Allyn Protocol, Inc. · Aug 2001
A&D MEDICAL TM-2550/TM-2551/TM-2560 VITAL SENSOR MONITOR
K002061 · A&D Engineering, Inc. · Jan 2001
ZOE MEDICAL NIGHTINGALE MONITORING SYSTEM
K001775 · Zoe Medical, Inc. · Jan 2001
MICROPAQ, MODELS 402 AND 404
K002725 · Protocol Systems, Inc. · Nov 2000
K010587 · ACTIVEECG
Download PDF FDA Summary Active Corp.