Cleared Traditional

K961395 - MEDI-TRACE RADIOLUCENT

K961395 is an FDA 510(k) clearance for MEDI-TRACE RADIOLUCENT, manufactured by Graphic Controls Corp.. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K961395 · Graphic Controls Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1996
Decision
57d
Days
Class 2
Risk

K961395 is an FDA 510(k) clearance for the MEDI-TRACE RADIOLUCENT. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Graphic Controls Corp. (Buafflo, US). The FDA issued a Cleared decision on June 7, 1996 after a review of 57 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 Graphic Controls Corp. devices

FDA 510(k) Submission Details - K961395

510(k) Number K961395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1996
Decision Date June 07, 1996
Days to Decision 57 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
68d faster than avg
Panel avg: 125d · This submission: 57d
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 190
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K961395.
QUICKELS QS 200 SYSTEM
K954772 · Ferguson Medical · Jul 1996
QUICKELS QS 100 SYSTEM
K954773 · Ferguson Medical · Jul 1996
DISPOSABLE ECG ELECTRODE
K953649 · Kendall-Ltp · Jun 1996
UNILECT, MONITAB AND BIOTRACE-HR
K944497 · Msb , Ltd. · May 1996
SI2000 (SENSE-IT TRADEMARK) OR G2000
K955800 · Cmc Sense-It, Inc. · May 1996
BIOTRACE-N, NS, 410 AND RT
K944496 · Msb , Ltd. · May 1996