Cleared Traditional

MODEL 78670A (K823268) - FDA 510(k) Clearance

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

K823268 · Hewlett-Packard Co. · Cardiovascular device
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Jan 1983
Decision
85d
Days
Class 2
Risk

K823268 is an FDA 510(k) clearance for the MODEL 78670A. Classified as Dc-defibrillator, Low-energy, (including Paddles) (product code LDD), Class II - Special Controls.

Submitted by Hewlett-Packard Co. (Walker, US). The FDA issued a Cleared decision on January 26, 1983 after a review of 85 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 Hewlett-Packard Co. devices

Submission Details

510(k) Number K823268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1982
Decision Date January 26, 1983
Days to Decision 85 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
40d faster than avg
Panel avg: 125d · This submission: 85d
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 K823268.
MODELS 43100A, 43110A & 43120A DEFIBRILLATOR/MONIT
K844740 · Hewlett-Packard Co. · Feb 1985
TEC-3500 DEFIBRILLATOR
K840258 · Nihon Kohden America, Inc. · May 1984
THERACARD 400
K823828 · Siemens Medical Solutions USA, Inc. · Mar 1983
DEFIBRILLATOR/MONITOR
K812317 · Hewlett-Packard Co. · Sep 1981