Cleared Traditional

K893403 - MODELS HP 43110MC, 43200MC W/CASE & 43200M NO CASE

K893403 is an FDA 510(k) clearance for MODELS HP 43110MC, manufactured by Hewlett-Packard Co.. The device is a Class 2 Cardiovascular device with product code LDD cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K893403 · Hewlett-Packard Co. · Cardiovascular device
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Aug 1989
Decision
94d
Days
Class 2
Risk

K893403 is an FDA 510(k) clearance for the MODELS HP 43110MC, 43200MC W/CASE & 43200M NO CASE. Classified as Dc-defibrillator, Low-energy, (including Paddles) (product code LDD), Class II - Special Controls.

Submitted by Hewlett-Packard Co. (Mcminnville, US). The FDA issued a Cleared decision on August 3, 1989 after a review of 94 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 Hewlett-Packard Co. devices

FDA 510(k) Submission Details - K893403

510(k) Number K893403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1989
Decision Date August 03, 1989
Days to Decision 94 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
31d faster than avg
Panel avg: 125d · This submission: 94d
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 115
Devices cleared under the same product code (LDD) and FDA review panel - the closest regulatory comparables to K893403.
DEFIB K-PADS
K895662 · Katecho, Inc. · Jan 1990
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K895651 · Marquette Electronics, Inc. · Dec 1989
COORDINATOR
K895113 · Cardiotronics, Inc. · Oct 1989
LIFEPAK 10 DEFIBRILLATOR/MONITOR
K890079 · Physio-Control Corp. · Feb 1989
LIFEPAK 50 MONITOR/DEFIBRILLATOR
K883617 · Physio-Control Corp. · Dec 1988
CARDIOLIFE TEC-7300 W/OPTIONAL ACCESSORIES
K880575 · Nihon Kohden America, Inc. · Aug 1988