Cleared Traditional

K832833 - PERSONAL DEFIBRILLATOR

K832833 is an FDA 510(k) clearance for PERSONAL DEFIBRILLATOR, manufactured by Physio-Control, Inc.. The device is a Class 2 Cardiovascular device with product code LDD cleared through the Traditional 510(k) pathway after a 434-day FDA review.

K832833 · Physio-Control, Inc. · Cardiovascular device
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Oct 1984
Decision
434d
Days
Class 2
Risk

K832833 is an FDA 510(k) clearance for the PERSONAL DEFIBRILLATOR. Classified as Dc-defibrillator, Low-energy, (including Paddles) (product code LDD), Class II - Special Controls.

Submitted by Physio-Control, Inc. (Redmond, US). The FDA issued a Cleared decision on October 26, 1984 after a review of 434 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Physio-Control, Inc. devices

FDA 510(k) Submission Details - K832833

510(k) Number K832833 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1983
Decision Date October 26, 1984
Days to Decision 434 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
309d slower than avg
Panel avg: 125d · This submission: 434d
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 89
Devices cleared under the same product code (LDD) and FDA review panel - the closest regulatory comparables to K832833.
MODELS 43100A, 43110A & 43120A DEFIBRILLATOR/MONIT
K844740 · Hewlett-Packard Co. · Feb 1985
CARDIOPAC DEFIBRILLATOR 444
K844103 · Birtcher Corp. · Jan 1985
M/D4 W/CHARGER (CARDIOPAC 3M11)
K844447 · Datascope Corp. · Jan 1985
LIFEPAK 8
K842624 · Physio-Control Corp. · Oct 1984
LIFEPAK 200
K843229 · Physio-Control Corp. · Oct 1984
EXTERNAL PEDIATRIC DEFIBRILLATOR PADDLE
K842667 · Marquette Electronics, Inc. · Aug 1984