Cleared Traditional

K822616 - LS6 ARRYTHMIA DISCRIMINATOR

K822616 is an FDA 510(k) clearance for LS6 ARRYTHMIA DISCRIMINATOR, manufactured by Life Science Instrumentation, Inc.. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K822616 · Life Science Instrumentation, Inc. · Cardiovascular device
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Oct 1982
Decision
49d
Days
Class 2
Risk

K822616 is an FDA 510(k) clearance for the LS6 ARRYTHMIA DISCRIMINATOR. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Life Science Instrumentation, Inc. (Walker, US). The FDA issued a Cleared decision on October 18, 1982 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - 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 Life Science Instrumentation, Inc. devices

FDA 510(k) Submission Details - K822616

510(k) Number K822616 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1982
Decision Date October 18, 1982
Days to Decision 49 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
76d faster than avg
Panel avg: 125d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSI Device Classification - Class 2, Special Controls

Product Code DSI Detector And Alarm, Arrhythmia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
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 - DSI Detector And Alarm, Arrhythmia

All 261
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K822616.
SIRECUST 400
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MULTIPLE LEAD ARRHYTHMIA MODULE
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MEMOPORT C
K820881 · Litton Medical Electronics · May 1982