Cleared Traditional

K892067 - MT9000 CHART RECORDER

K892067 is an FDA 510(k) clearance for MT9000 CHART RECORDER, manufactured by Astro-Med, Inc.. The device is a Class 2 Cardiovascular device with product code DSH cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K892067 · Astro-Med, Inc. · Cardiovascular device
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Jun 1989
Decision
67d
Days
Class 2
Risk

K892067 is an FDA 510(k) clearance for the MT9000 CHART RECORDER. Classified as Recorder, Magnetic Tape, Medical (product code DSH), Class II - Special Controls.

Submitted by Astro-Med, Inc. (West Warwick, US). The FDA issued a Cleared decision on June 5, 1989 after a review of 67 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 Astro-Med, Inc. devices

FDA 510(k) Submission Details - K892067

510(k) Number K892067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1989
Decision Date June 05, 1989
Days to Decision 67 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 125d · This submission: 67d
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 113
Devices cleared under the same product code (DSH) and FDA review panel - the closest regulatory comparables to K892067.
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
MEDILOG 9000-II AMBULATORY RECORDER
K890647 · Oxford Medilog, Inc. · Mar 1989
MODEL 463 ELECTROCARDIORECORDER RECORDER
K884330 · Del Mar Avionics · Jan 1989
MODEL 459 ELECTROCARDIOCORDER RECORDER
K884009 · Del Mar Avionics · Nov 1988