Cleared Traditional

CARDIOLIFE TEC-7300 W/OPTIONAL ACCESSORIES (K880575) - FDA 510(k) Clearance

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

K880575 · Nihon Kohden America, Inc. · Cardiovascular device
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Aug 1988
Decision
174d
Days
Class 2
Risk

K880575 is an FDA 510(k) clearance for the CARDIOLIFE TEC-7300 W/OPTIONAL ACCESSORIES. Classified as Dc-defibrillator, Low-energy, (including Paddles) (product code LDD), Class II - Special Controls.

Submitted by Nihon Kohden America, Inc. (Irvine, US). The FDA issued a Cleared decision on August 2, 1988 after a review of 174 days - an extended review 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: 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

Submission Details

510(k) Number K880575 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1988
Decision Date August 02, 1988
Days to Decision 174 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
49d slower than avg
Panel avg: 125d · This submission: 174d
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 20
Devices cleared under the same product code (LDD) and FDA review panel - the closest regulatory comparables to K880575.
TEC-8251A DEFIBRILLATOR MONITOR, MODIFICATION
K914971 · Nihon Kohden America, Inc. · Dec 1991
MODEL 43100A SERIES DEFIBRILLATOR, MODIFICATION
K910754 · Hewlett-Packard Co. · May 1991
MODELS HP 43110MC, 43200MC W/CASE & 43200M NO CASE
K893403 · Hewlett-Packard Co. · Aug 1989
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