Cleared Traditional

K883121 - QUIK-PACE II ELECTRODES

K883121 is an FDA 510(k) clearance for QUIK-PACE II ELECTRODES, manufactured by Physio-Control Corp.. The device is a Class 2 Cardiovascular device with product code DRO cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K883121 · Physio-Control Corp. · Cardiovascular device
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Sep 1988
Decision
56d
Days
Class 2
Risk

K883121 is an FDA 510(k) clearance for the QUIK-PACE II ELECTRODES. Classified as Pacemaker, Cardiac, External Transcutaneous (non-invasive) (product code DRO), Class II - Special Controls.

Submitted by Physio-Control Corp. (Redmond, US). The FDA issued a Cleared decision on September 20, 1988 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5550 - 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 Physio-Control Corp. devices

FDA 510(k) Submission Details - K883121

510(k) Number K883121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1988
Decision Date September 20, 1988
Days to Decision 56 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 125d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRO Device Classification - Class 2, Special Controls

Product Code DRO Pacemaker, Cardiac, External Transcutaneous (non-invasive)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5550
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 - DRO Pacemaker, Cardiac, External Transcutaneous (non-invasive)

All 40
Devices cleared under the same product code (DRO) and FDA review panel - the closest regulatory comparables to K883121.
TRIAD-EP, PUSHBUTTON, CABLE INPUT TYPE
K883178 · Cardiotronics, Inc. · Nov 1988
TRAID-EP, PLATE INPUT, W/PULSE BLANKING CIRCUITRY
K883304 · Cardiotronics, Inc. · Nov 1988
TRIAD-EP, PUSHBUTTON, CABLE INPUT TYPE, W/PULSE
K883523 · Cardiotronics, Inc. · Oct 1988
MODEL #716 ADULT STIM. PADS LOW IMPEDANCE GEL TYPE
K882338 · Cardiotronics, Inc. · Aug 1988
MODEL #918 MULTI-PADS
K883375 · Cardiotronics, Inc. · Aug 1988
TRIAD-EP
K880936 · Cardiotronics, Inc. · Jul 1988