Cleared Traditional

K943301 - QUIK COMBO

K943301 is an FDA 510(k) clearance for QUIK COMBO, manufactured by Physio-Control Corp.. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K943301 · Physio-Control Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1995
Decision
210d
Days
Class 2
Risk

K943301 is an FDA 510(k) clearance for the QUIK COMBO. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Physio-Control Corp. (Redmond, US). The FDA issued a Cleared decision on February 3, 1995 after a review of 210 days - an extended review 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: 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 Physio-Control Corp. devices

FDA 510(k) Submission Details - K943301

510(k) Number K943301 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1994
Decision Date February 03, 1995
Days to Decision 210 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
85d slower than avg
Panel avg: 125d · This submission: 210d
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 130
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K943301.
GRAPHIC CONTROLS Q-TRACE ECG ELECTRODE
K950486 · Graphic Controls Corp. · May 1995
GRAPHIC CONTROLS Q-TRACE GOLD ECG ELECTRODE
K950487 · Graphic Controls Corp. · May 1995
EKG VEST
K932903 · Cardiotronics, Inc. · Feb 1995
TRIGEL MULTIFUNCTION ELECTRODE
K934505 · Physiometrix, Inc. · Nov 1994
MEDI-TRACE NEONATAL ECG ELECTRODE WITH PREATTACHED LEADWIRE
K945214 · Graphic Controls Corp. · Nov 1994
K-KLIP
K940801 · Katecho, Inc. · Aug 1994