Cleared Traditional

K915159 - PEDIATRIC MULTI-FUNCTION ELECTRODES

K915159 is the FDA 510(k) clearance for PEDIATRIC MULTI-FUNCTION ELECTRODES by Zmi Corp.. It is a Class 2 Cardiovascular device (product code DRF) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K915159 · Zmi Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1992
Decision
85d
Days
Class 2
Risk

K915159 is an FDA 510(k) clearance for the PEDIATRIC MULTI-FUNCTION ELECTRODES. Classified as Catheter, Electrode Recording, Or Probe, Electrode Recording (product code DRF), Class II - Special Controls.

Submitted by Zmi Corp. (Woburn, US). The FDA issued a Cleared decision on February 7, 1992 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1220 - 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 Zmi Corp. devices

Submission Details

510(k) Number K915159 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1991
Decision Date February 07, 1992
Days to Decision 85 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 125d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1220
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 - DRF Catheter, Electrode Recording, Or Probe, Electrode Recording

All 98
Devices cleared under the same product code (DRF) and FDA review panel - the closest regulatory comparables to K915159.
EXPLORER/360-POLARIS-L.E./JACKMAN CORON SINUS ELEC
K924163 · Boston Scientific Corp · Sep 1993
ARROW QUADPOLAR MAPPING/PACING CATHETER
K911065 · Arrow Intl., Inc. · Jun 1992
DAIG ELECTROPHYSIOLOGY CATHETER W/INFUSION LUMEN
K914278 · Daig Corp. · Mar 1992
MEDTRONIC MODEL 5407S, 5807S & 5410S SURG CABLES
K914460 · Medtronic Vascular · Nov 1991
BARD(R) ENDOCARDIAL BALLOON ARRAY
K911140 · C.R. Bard, Inc. · May 1991
MODIFIED EPICARDIAL ARRAY
K902228 · C.R. Bard, Inc. · Jul 1990