Cleared Traditional

K860636 - FASTRACE III, ECG ELECTRODE (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K860636 · Andover Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1986
Decision
77d
Days
Class 2
Risk

K860636 is an FDA 510(k) clearance for the FASTRACE III, ECG ELECTRODE. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Andover Medical, Inc. (Lawrence, US). The FDA issued a Cleared decision on May 9, 1986 after a review of 77 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Andover Medical, Inc. devices

Submission Details

510(k) Number K860636 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1986
Decision Date May 09, 1986
Days to Decision 77 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 125d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 574
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K860636.
MAC 7 Resting ECG Analysis System
K251670 · Ge Medical Systems Information Technologies, Inc. · Jan 2026
AccurECG Analysis System (v2.0)
K252361 · Accurkardia, Inc. · Dec 2025
Withings BeamO (SCT02)
K252474 · Withings · Nov 2025
Cardiologs Holter Platform
K250569 · Philips France Commercial · Aug 2025
ZBPro Diagnostic
K243252 · Zbeats, Inc. · Jul 2025
Masimo W1
K243305 · Masimo Corporation · Apr 2025