Cleared Traditional

K840258 - TEC-3500 DEFIBRILLATOR

K840258 is an FDA 510(k) clearance for TEC-3500 DEFIBRILLATOR, manufactured by Nihon Kohden America, Inc.. The device is a Class 2 Cardiovascular device with product code LDD cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K840258 · Nihon Kohden America, Inc. · Cardiovascular device
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May 1984
Decision
121d
Days
Class 2
Risk

K840258 is an FDA 510(k) clearance for the TEC-3500 DEFIBRILLATOR. Classified as Dc-defibrillator, Low-energy, (including Paddles) (product code LDD), Class II - Special Controls.

Submitted by Nihon Kohden America, Inc. (Foothill, US). The FDA issued a Cleared decision on May 23, 1984 after a review of 121 days - within the typical 510(k) review window.

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. 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 Nihon Kohden America, Inc. devices

FDA 510(k) Submission Details - K840258

510(k) Number K840258 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1984
Decision Date May 23, 1984
Days to Decision 121 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
4d faster than avg
Panel avg: 125d · This submission: 121d
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 86
Devices cleared under the same product code (LDD) and FDA review panel - the closest regulatory comparables to K840258.
LIFEPAK 8
K842624 · Physio-Control Corp. · Oct 1984
LIFEPAK 200
K843229 · Physio-Control Corp. · Oct 1984
EXTERNAL PEDIATRIC DEFIBRILLATOR PADDLE
K842667 · Marquette Electronics, Inc. · Aug 1984
PORTABLE DEFIBRILLATOR
K840167 · Honeywell, Inc. · Feb 1984
PORTABLE DEFIBRILLATOR MONITOR 74DRK
K831696 · Honeywell, Inc. · Nov 1983
THERACARD 400
K823828 · Siemens Medical Solutions USA, Inc. · Mar 1983