Cleared Traditional

K832693 - ARRHYTHMIA III CARDULE #1919

K832693 is an FDA 510(k) clearance for ARRHYTHMIA III CARDULE #1919, manufactured by Spacelabs, Inc.. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K832693 · Spacelabs, Inc. · Cardiovascular device
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Nov 1983
Decision
89d
Days
Class 2
Risk

K832693 is an FDA 510(k) clearance for the ARRHYTHMIA III CARDULE #1919. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Spacelabs, Inc. (Walker, US). The FDA issued a Cleared decision on November 7, 1983 after a review of 89 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 Spacelabs, Inc. devices

FDA 510(k) Submission Details - K832693

510(k) Number K832693 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1983
Decision Date November 07, 1983
Days to Decision 89 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
36d faster than avg
Panel avg: 125d · This submission: 89d
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 238
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K832693.
LEAP FROG
K834211 · Philips Medical Systems (Cleveland), Inc. · Jun 1984
ALPHA MASS STORAGE CARDULE 1895
K834597 · Spacelabs, Inc. · Apr 1984
AMBULATORY MONITORING DEVICE
K833162 · Oxford Medilog, Inc. · Jan 1984
WLECTROCARDIOGRAPH ECG-7204
K831274 · Nihon Kohden America, Inc. · Oct 1983
SIRECUST 400
K830029 · Analogic Corp. · Mar 1983
HEARTRATE PLUS ECG CARDULE #1918
K830306 · Spacelabs, Inc. · Mar 1983