Cleared Traditional

K882337 - MODEL #825 ADULT STIM. PADS POLYMER TYPE

K882337 is an FDA 510(k) clearance for MODEL #825 ADULT STIM. PADS POLYMER TYPE, manufactured by Cardiotronics, Inc.. The device is a Class 2 Cardiovascular device with product code LDD cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K882337 · Cardiotronics, Inc. · Cardiovascular device
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Aug 1988
Decision
57d
Days
Class 2
Risk

K882337 is an FDA 510(k) clearance for the MODEL #825 ADULT STIM. PADS POLYMER TYPE. Classified as Dc-defibrillator, Low-energy, (including Paddles) (product code LDD), Class II - Special Controls.

Submitted by Cardiotronics, Inc. (West Carlsbad, US). The FDA issued a Cleared decision on August 2, 1988 after a review of 57 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 Cardiotronics, Inc. devices

FDA 510(k) Submission Details - K882337

510(k) Number K882337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1988
Decision Date August 02, 1988
Days to Decision 57 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
68d faster than avg
Panel avg: 125d · This submission: 57d
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 81
Devices cleared under the same product code (LDD) and FDA review panel - the closest regulatory comparables to K882337.
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
LIFEPAK 9 DEFIBRILLATOR AND CARDIAC MONITOR
K881153 · Physio-Control Corp. · Jul 1988
FAST-PATCH(TM)
K871224 · Physio-Control Corp. · May 1987
CARDIOLIFE TEC 7100
K863404 · Nihon Kohden America, Inc. · Oct 1986