Cleared Traditional

K912427 - MULTICHANNEL RECORDING SYSTEM

K912427 is an FDA 510(k) clearance for MULTICHANNEL RECORDING SYSTEM, manufactured by Bionique. The device is a Class 2 Cardiovascular device with product code DSH cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K912427 · Bionique · Cardiovascular device
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Jul 1991
Decision
56d
Days
Class 2
Risk

K912427 is an FDA 510(k) clearance for the MULTICHANNEL RECORDING SYSTEM. Classified as Recorder, Magnetic Tape, Medical (product code DSH), Class II - Special Controls.

Submitted by Bionique (Beaverton, US). The FDA issued a Cleared decision on July 26, 1991 after a review of 56 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 Bionique devices

FDA 510(k) Submission Details - K912427

510(k) Number K912427 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1991
Decision Date July 26, 1991
Days to Decision 56 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
69d faster than avg
Panel avg: 125d · This submission: 56d
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 K912427.
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PR4
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MODEL 9101 RECORDER/ANALYZER SYSTEM
K901251 · Aequitron Medical, Inc. · May 1990
MICROPOTENTIAL ANALYZER/SPECTROCARDIOGRAPHY OPTION
K895793 · Del Mar Avionics · Feb 1990
EDENTEC MODEL 2001 MODULAR MEMORY UNIT (MMU)
K892227 · Edentec Corp. · Jun 1989