Cleared Traditional

K902486 - CARDIOVISTA

K902486 is an FDA 510(k) clearance for CARDIOVISTA, manufactured by Cardionostics, Inc.. The device is a Class 2 Cardiovascular device with product code DSH cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K902486 · Cardionostics, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1990
Decision
80d
Days
Class 2
Risk

K902486 is an FDA 510(k) clearance for the CARDIOVISTA. Classified as Recorder, Magnetic Tape, Medical (product code DSH), Class II - Special Controls.

Submitted by Cardionostics, Inc. (Tustin, US). The FDA issued a Cleared decision on August 23, 1990 after a review of 80 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 Cardionostics, Inc. devices

FDA 510(k) Submission Details - K902486

510(k) Number K902486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1990
Decision Date August 23, 1990
Days to Decision 80 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 125d · This submission: 80d
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 K902486.
SPACELAB MODEL 90845 PCMS MULTIDISCLOSURE STATION
K913038 · Spacelabs, Inc. · Oct 1991
MR-5200 FULL DISCLOSURE SYSTEM
K911257 · Mennen Medical, Inc. · Aug 1991
PR4
K911097 · Mortara Instrument, Inc. · Aug 1991
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