Cleared Traditional

K954066 - MINISCOPE MS-3

K954066 is an FDA 510(k) clearance for MINISCOPE MS-3, manufactured by Schiller America, Inc.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K954066 · Schiller America, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
58d
Days
Class 2
Risk

K954066 is an FDA 510(k) clearance for the MINISCOPE MS-3. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Schiller America, Inc. (Tustin, US). The FDA issued a Cleared decision on October 27, 1995 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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.

FDA 510(k) Submission Details - K954066

510(k) Number K954066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1995
Decision Date October 27, 1995
Days to Decision 58 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 125d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPS Device Classification - Class 2, Special Controls

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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 - DPS Electrocardiograph

All 494
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K954066.
PC ECG 1200 ECG AND STRESS ELECTROCARDIOGRAPHY TESTING SYSTEM(VERSION 2.90)
K960449 · Biosensor Corp. · May 1996
CARDIOSMART
K950989 · Hellige GmbH · May 1996
CAMBRIDGE HEART CH 2000 STRESS TEST SYSTEM
K950018 · Cambridge Heart, Inc. · Feb 1996
HEARTVIEW(TM) 12-LEAD ELECTROCARDIOGRAPH RECORDER/TRANSMITTER
K950004 · Aerotel, Ltd. · Oct 1995
6200 VITAL SIGNS MONITOR
K953415 · Bci Intl., Inc. · Oct 1995
HEWLETT-PACKARD MODEL M1264B CATHSTATION
K952173 · Hewlett-Packard Co. · Aug 1995
K954066 · MINISCOPE MS-3
Download PDF Schiller America, Inc.