Cleared Traditional

K960264 - CONMED EKG STRIPPER

K960264 is an FDA 510(k) clearance for CONMED EKG STRIPPER, manufactured by Conmedcorp. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K960264 · Conmedcorp · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
82d
Days
Class 2
Risk

K960264 is an FDA 510(k) clearance for the CONMED EKG STRIPPER. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Conmedcorp (Dayton, US). The FDA issued a Cleared decision on April 9, 1996 after a review of 82 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 Conmedcorp devices

FDA 510(k) Submission Details - K960264

510(k) Number K960264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1996
Decision Date April 09, 1996
Days to Decision 82 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 125d · This submission: 82d
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 117
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K960264.
QUICKELS QS 100 SYSTEM
K954773 · Ferguson Medical · Jul 1996
MEDI-TRACE RADIOLUCENT
K961395 · Graphic Controls Corp. · Jun 1996
CONMED ECG/EKG ELECTRODES
K954389 · Conmedcorp · May 1996
CONMED 2710 CLEARTRACE 2 LT MONITORING ECG ELECTRODE
K954388 · Conmedcorp · Feb 1996
MEDI-TRACE(R) 500 ECG ELECTRODE
K945479 · Graphic Controls Corp. · Jul 1995
GRAPHIC CONTROLS PROTRACE ECG ELECTRODE
K950485 · Graphic Controls Corp. · Jul 1995