Cleared Traditional

MODEL 617D (K863303) - FDA 510(k) Clearance

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

K863303 · Quinton, Inc. · Cardiovascular device

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Sep 1986

Decision

11d

Days

Class 2

Risk

K863303 is an FDA 510(k) clearance for the MODEL 617D. Classified as Dc-defibrillator, Low-energy, (including Paddles) (product code LDD), Class II - Special Controls.

Submitted by Quinton, Inc. (Seattle, US). The FDA issued a Cleared decision on September 5, 1986 after a review of 11 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 Quinton, Inc. devices

Submission Details

510(k) Number	K863303 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 25, 1986
Decision Date	September 05, 1986
Days to Decision	11 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

114d faster than avg

Panel avg: 125d · This submission: 11d

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 18

Devices cleared under the same product code (LDD) and FDA review panel - the closest regulatory comparables to K863303.

CARDIOLIFE TEC-7300 W/OPTIONAL ACCESSORIES

K880575 · Nihon Kohden America, Inc. · Aug 1988

CARDIOLIFE TEC 7100

K863404 · Nihon Kohden America, Inc. · Oct 1986

CARDIOLIFE TEC 7200

K863405 · Nihon Kohden America, Inc. · Oct 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

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K863303

Quinton, Inc.

Seattle, WA · US

RON R DUCK

Regulatory profile

164 submissions 160 cleared

98% clearance rate · Active in Cardiovascular

Data Intelligence Layer

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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