Cleared Traditional

K864257 - TELEPHONE DEFIBRILLATOR SYSTEM

K864257 is an FDA 510(k) clearance for TELEPHONE DEFIBRILLATOR SYSTEM, manufactured by Medphone Corp.. The device is a Class 2 Cardiovascular device with product code LDD cleared through the Traditional 510(k) pathway after a 394-day FDA review.

K864257 · Medphone Corp. · Cardiovascular device
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Nov 1987
Decision
394d
Days
Class 2
Risk

K864257 is an FDA 510(k) clearance for the TELEPHONE DEFIBRILLATOR SYSTEM. Classified as Dc-defibrillator, Low-energy, (including Paddles) (product code LDD), Class II - Special Controls.

Submitted by Medphone Corp. (Washington, US). The FDA issued a Cleared decision on November 27, 1987 after a review of 394 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Medphone Corp. devices

FDA 510(k) Submission Details - K864257

510(k) Number K864257 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1986
Decision Date November 27, 1987
Days to Decision 394 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
269d slower than avg
Panel avg: 125d · This submission: 394d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LDD Device Classification - Class 2, Special Controls

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 117
Devices cleared under the same product code (LDD) and FDA review panel - the closest regulatory comparables to K864257.
MODEL #825 ADULT STIM. PADS POLYMER TYPE
K882337 · Cardiotronics, Inc. · Aug 1988
LIFEPAK 9 DEFIBRILLATOR AND CARDIAC MONITOR
K881153 · Physio-Control Corp. · Jul 1988
450SLL DEFIBRILLATOR
K874204 · Medical Research Laboratories, Inc. · Jan 1988
FAST-PATCH(TM)
K871224 · Physio-Control Corp. · May 1987
K-STIK DEFIBRILLATION PADS
K863899 · Katecho, Inc. · Nov 1986
CARDIOLIFE TEC 7100
K863404 · Nihon Kohden America, Inc. · Oct 1986