Cleared Traditional

K913600 - WRISTRECORDER CARDIAC EVENT RECORDING SYSTEM

K913600 is an FDA 510(k) clearance for WRISTRECORDER CARDIAC EVENT RECORDING S..., manufactured by Ralin Laboratories, Inc.. The device is a Class 2 Cardiovascular device with product code DSH cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K913600 · Ralin Laboratories, Inc. · Cardiovascular device
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Oct 1991
Decision
64d
Days
Class 2
Risk

K913600 is an FDA 510(k) clearance for the WRISTRECORDER CARDIAC EVENT RECORDING SYSTEM. Classified as Recorder, Magnetic Tape, Medical (product code DSH), Class II - Special Controls.

Submitted by Ralin Laboratories, Inc. (Beaverton, US). The FDA issued a Cleared decision on October 16, 1991 after a review of 64 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 Ralin Laboratories, Inc. devices

FDA 510(k) Submission Details - K913600

510(k) Number K913600 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1991
Decision Date October 16, 1991
Days to Decision 64 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 125d · This submission: 64d
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 121
Devices cleared under the same product code (DSH) and FDA review panel - the closest regulatory comparables to K913600.
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