Cleared Traditional

K881085 - SOFT-E SERIES T-10 ACCUTRACE TAB RESTING ELECTRODE

K881085 is an FDA 510(k) clearance for SOFT-E SERIES T-10 ACCUTRACE TAB RESTIN..., manufactured by Contour Electrodes, Inc.. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K881085 · Contour Electrodes, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1988
Decision
34d
Days
Class 2
Risk

K881085 is an FDA 510(k) clearance for the SOFT-E SERIES T-10 ACCUTRACE TAB RESTING ELECTRODE. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Contour Electrodes, Inc. (Herrin, US). The FDA issued a Cleared decision on April 11, 1988 after a review of 34 days - a notably fast clearance cycle.

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: 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 Contour Electrodes, Inc. devices

FDA 510(k) Submission Details - K881085

510(k) Number K881085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1988
Decision Date April 11, 1988
Days to Decision 34 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 125d · This submission: 34d
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 188
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K881085.
BARD TAB ECG MONITORING ELECTRODE
K890103 · C.R. Bard, Inc. · Jan 1989
BARD MULTI-TAC ECG MONITORING ELECTRODE
K884064 · C.R. Bard, Inc. · Oct 1988
SYNCOR (R) MODEL S-801 ECG ELECTRODE
K882216 · Lectec Corp. · Jul 1988
STAND. CLEAR VINYL DISPOSABLE ECG ELECT.(594 ADHE)
K872866 · Labeltape Meditect, Inc. · Jan 1988
PRE-GELLED DISPOSABLE ECG ELECTRODE - HP13941A
K874421 · Hewlett-Packard Co. · Jan 1988
PRE-GELLED DISPOSABLE CLEAR TAPE ECG ELEC.HP13942D
K874422 · Hewlett-Packard Co. · Jan 1988