Cleared Traditional

MEDIC 4 (K853354) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K853354 · Kone Instruments, Inc. · Cardiovascular device
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Oct 1985
Decision
60d
Days
Class 2
Risk

K853354 is an FDA 510(k) clearance for the MEDIC 4. Classified as Dc-defibrillator, Low-energy, (including Paddles) (product code LDD), Class II - Special Controls.

Submitted by Kone Instruments, Inc. (Milton, US). The FDA issued a Cleared decision on October 11, 1985 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5300 - 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 Kone Instruments, Inc. devices

Submission Details

510(k) Number K853354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1985
Decision Date October 11, 1985
Days to Decision 60 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 125d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LDD Dc-defibrillator, Low-energy, (including Paddles)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5300
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 - LDD Dc-defibrillator, Low-energy, (including Paddles)

All 19
Devices cleared under the same product code (LDD) and FDA review panel - the closest regulatory comparables to K853354.
CARDIOLIFE TEC 7100
K863404 · Nihon Kohden America, Inc. · Oct 1986
CARDIOLIFE TEC 7200
K863405 · Nihon Kohden America, Inc. · Oct 1986
MODEL 617D
K863303 · Quinton, Inc. · Sep 1986
MODEL 43130A DEFIBRILLATOR
K853439 · Hewlett-Packard Co. · Oct 1985
MODELS 43100A, 43110A & 43120A DEFIBRILLATOR/MONIT
K844740 · Hewlett-Packard Co. · Feb 1985
TEC-3500 DEFIBRILLATOR
K840258 · Nihon Kohden America, Inc. · May 1984