Cleared Traditional

K831262 - DATA IV AMBULATORY MONITOR

K831262 is an FDA 510(k) clearance for DATA IV AMBULATORY MONITOR, manufactured by Cardio-Scan of Texas. The device is a Class 2 Cardiovascular device with product code DSH cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K831262 · Cardio-Scan of Texas · Cardiovascular device
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May 1983
Decision
37d
Days
Class 2
Risk

K831262 is an FDA 510(k) clearance for the DATA IV AMBULATORY MONITOR. Classified as Recorder, Magnetic Tape, Medical (product code DSH), Class II - Special Controls.

Submitted by Cardio-Scan of Texas (Mchenry, US). The FDA issued a Cleared decision on May 25, 1983 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2800 - 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 Cardio-Scan of Texas devices

FDA 510(k) Submission Details - K831262

510(k) Number K831262 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1983
Decision Date May 25, 1983
Days to Decision 37 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 125d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSH Device Classification - Class 2, Special Controls

Product Code DSH Recorder, Magnetic Tape, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2800
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 - DSH Recorder, Magnetic Tape, Medical

All 123
Devices cleared under the same product code (DSH) and FDA review panel - the closest regulatory comparables to K831262.
ELECTROCARDIOCORDER RECORDER 453
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AMBULATORY ECG EVENT RECORDER
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OMAR
K830915 · Oxford Medilog, Inc. · Jul 1983
HOLTER RECORDER & PLAYBACK/ANALYSIS SYS
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HOLTER KIT MODEL #5000 SERIES
K823414 · Andover Medical, Inc. · Dec 1982
CARDIOCASSETTE II #363
K821453 · Birtcher Corp. · May 1982