Cleared Traditional

K962115 - CAMBRIDGE HEART HI-RES ECG ELECTRODE

K962115 is an FDA 510(k) clearance for CAMBRIDGE HEART HI-RES ECG ELECTRODE, manufactured by Cambridge Heart, Inc.. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K962115 · Cambridge Heart, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
90d
Days
Class 2
Risk

K962115 is an FDA 510(k) clearance for the CAMBRIDGE HEART HI-RES ECG ELECTRODE. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Cambridge Heart, Inc. (Bedford, US). The FDA issued a Cleared decision on August 29, 1996 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2360 - 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 Cambridge Heart, Inc. devices

FDA 510(k) Submission Details - K962115

510(k) Number K962115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1996
Decision Date August 29, 1996
Days to Decision 90 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
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRX Device Classification - Class 2, Special Controls

Product Code DRX Electrode, Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2360
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 - DRX Electrode, Electrocardiograph

All 147
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K962115.
MEDI-TRACE 5700 RESTING ECG ELECTRODE
K963151 · Graphic Controls Corp. · Nov 1996
MEDI-TRACE 3600 SERIES OF ECG MONITORING ELECTRODE
K963038 · Graphic Controls Corp. · Nov 1996
MEDI-TRACE 200, MEDI-TRACE 200-30
K960968 · Graphic Controls Corp. · Oct 1996
BODYTRODE
K961288 · Marquette Electronics, Inc. · Aug 1996
QUICKELS QS 200 SYSTEM
K954772 · Ferguson Medical · Jul 1996
QUICKELS QS 100 SYSTEM
K954773 · Ferguson Medical · Jul 1996