Cleared Traditional

K953415 - 6200 VITAL SIGNS MONITOR

K953415 is an FDA 510(k) clearance for 6200 VITAL SIGNS MONITOR, manufactured by Bci Intl., Inc.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K953415 · Bci Intl., Inc. · Cardiovascular device
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Oct 1995
Decision
91d
Days
Class 2
Risk

K953415 is an FDA 510(k) clearance for the 6200 VITAL SIGNS MONITOR. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Bci Intl., Inc. (Waukesha, US). The FDA issued a Cleared decision on October 19, 1995 after a review of 91 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Bci Intl., Inc. devices

FDA 510(k) Submission Details - K953415

510(k) Number K953415 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1995
Decision Date October 19, 1995
Days to Decision 91 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 125d · This submission: 91d
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 304
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K953415.
DINAMAP SELECT MULTI-PARAMETER SYSTEM
K955113 · Johnson & Johnson Medical, Inc. · Aug 1996
CARDIMAX MODEL FX-2111
K955416 · Fukuda Denshi USA, Inc. · Jul 1996
NELLCOR SYMPHONY N-3000 PATIENT MONITOR W/SP02 & ECG/N-3200 DISPLAY/PRINTER
K955642 · Nellcor Puritan Bennett, Inc. · Jul 1996
HEWLETT-PACKARD MODEL M1264B CATHSTATION
K952173 · Hewlett-Packard Co. · Aug 1995
QUINTON MODEL 710 STRESS ELECTROCARDIOGRAPH
K945626 · Quinton, Inc. · Jun 1995
DINAMAP PLUS VITAL SIGNS MONOITOR
K943709 · Critikon Company, LLC · Jun 1995