Cleared Traditional

K842640 - SPACELABS ICR ARRHYTHMIA MASTER I HOLTER

K842640 is an FDA 510(k) clearance for SPACELABS ICR ARRHYTHMIA MASTER I HOLTER, 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 86-day FDA review.

K842640 · Spacelabs, Inc. · Cardiovascular device
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Oct 1984
Decision
86d
Days
Class 2
Risk

K842640 is an FDA 510(k) clearance for the SPACELABS ICR ARRHYTHMIA MASTER I HOLTER. 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 October 4, 1984 after a review of 86 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 - K842640

510(k) Number K842640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1984
Decision Date October 04, 1984
Days to Decision 86 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
39d faster than avg
Panel avg: 125d · This submission: 86d
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 K842640.
PEDIATRIC DIAG. CRITERIA OPTION 5600C
K841416 · Hewlett-Packard Co. · Oct 1984
SPACELABS ALPHA PC PATIENT COMPUTER
K842616 · Spacelabs, Inc. · Oct 1984
ARRHYTHMIA CENTRAL OCC-7101
K843287 · Nihon Kohden America, Inc. · Oct 1984
LIFESCOPE 6 OEC-6201
K841500 · Nihon Kohden America, Inc. · Aug 1984
CARDIO EXPRESS 100 HOLTER SCANNER
K840622 · Del Mar Avionics · Jul 1984
LEAP FROG
K834211 · Philips Medical Systems (Cleveland), Inc. · Jun 1984