Cleared Traditional

K830306 - HEARTRATE PLUS ECG CARDULE #1918

K830306 is an FDA 510(k) clearance for HEARTRATE PLUS ECG CARDULE #1918, 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 45-day FDA review.

K830306 · Spacelabs, Inc. · Cardiovascular device
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Mar 1983
Decision
45d
Days
Class 2
Risk

K830306 is an FDA 510(k) clearance for the HEARTRATE PLUS ECG CARDULE #1918. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Spacelabs, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 17, 1983 after a review of 45 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 - K830306

510(k) Number K830306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1983
Decision Date March 17, 1983
Days to Decision 45 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
80d faster than avg
Panel avg: 125d · This submission: 45d
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 K830306.
ARRHYTHMIA III CARDULE #1919
K832693 · Spacelabs, Inc. · Nov 1983
WLECTROCARDIOGRAPH ECG-7204
K831274 · Nihon Kohden America, Inc. · Oct 1983
SIRECUST 400
K830029 · Analogic Corp. · Mar 1983
SERIES 7000 BEDSIDE PATIENT MONITOR
K822718 · Marquette Electronics, Inc. · Oct 1982
MULTIPLE LEAD ARRHYTHMIA MODULE
K822030 · Marquette Electronics, Inc. · Sep 1982
MEMOPORT C
K820881 · Litton Medical Electronics · May 1982