Cleared Traditional

K812317 - DEFIBRILLATOR/MONITOR

K812317 is the FDA 510(k) clearance for DEFIBRILLATOR/MONITOR by Hewlett-Packard Co.. It is a Class 2 Cardiovascular device (product code LDD) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K812317 · Hewlett-Packard Co. · Cardiovascular device
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Sep 1981
Decision
35d
Days
Class 2
Risk

K812317 is an FDA 510(k) clearance for the DEFIBRILLATOR/MONITOR. Classified as Dc-defibrillator, Low-energy, (including Paddles) (product code LDD), Class II - Special Controls.

Submitted by Hewlett-Packard Co. (Mchenry, US). The FDA issued a Cleared decision on September 21, 1981 after a review of 35 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 K812317 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1981
Decision Date September 21, 1981
Days to Decision 35 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
90d faster than avg
Panel avg: 125d · This submission: 35d
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 65
Devices cleared under the same product code (LDD) and FDA review panel - the closest regulatory comparables to K812317.
MODEL 78670A
K823268 · Hewlett-Packard Co. · Jan 1983
PORTA FIB III
K822961 · Narco Scientific · Nov 1982
LINE POWERED LOW ENERGY DEFIBRILLATOR II
K813471 · Narco Scientific · Dec 1981
DATASCOPE INTERNAL DEFIBRILLATOR PADDLES
K811638 · Datascope Corp. · Jul 1981
PORTABLE, BATTERY OPERATED DEFIBRILLATOR
K810237 · Honeywell, Inc. · Feb 1981