Cleared Traditional

K874697 - STRATUM D

K874697 is the FDA 510(k) clearance for STRATUM D by Alternative Design Systems, Inc.. It is a Class 2 Cardiovascular device (product code LDD) cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K874697 · Alternative Design Systems, Inc. · Cardiovascular device
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Dec 1987
Decision
26d
Days
Class 2
Risk

K874697 is an FDA 510(k) clearance for the STRATUM D. Classified as Dc-defibrillator, Low-energy, (including Paddles) (product code LDD), Class II - Special Controls.

Submitted by Alternative Design Systems, Inc. (Carlstadt, US). The FDA issued a Cleared decision on December 15, 1987 after a review of 26 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 Alternative Design Systems, Inc. devices

Submission Details

510(k) Number K874697 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1987
Decision Date December 15, 1987
Days to Decision 26 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 125d · This submission: 26d
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 50
Devices cleared under the same product code (LDD) and FDA review panel - the closest regulatory comparables to K874697.
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
CARDIOLIFE TEC 7200
K863405 · Nihon Kohden America, Inc. · Oct 1986