Cleared Traditional

K884896 - BP-308 MARK II

K884896 is an FDA 510(k) clearance for BP-308 MARK II, manufactured by Colin Medical Instruments Corp.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K884896 · Colin Medical Instruments Corp. · Cardiovascular device
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Feb 1989
Decision
93d
Days
Class 2
Risk

K884896 is an FDA 510(k) clearance for the BP-308 MARK II. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Colin Medical Instruments Corp. (South Plainfield, US). The FDA issued a Cleared decision on February 23, 1989 after a review of 93 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 Colin Medical Instruments Corp. devices

FDA 510(k) Submission Details - K884896

510(k) Number K884896 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 1988
Decision Date February 23, 1989
Days to Decision 93 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 125d · This submission: 93d
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 375
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K884896.
E350 ELECTROCARDIOGRAPH
K892835 · Burdick Corp. · Jun 1989
TYPE 9040 SYSTEM ATHENA
K884116 · S & W Medico Teknik · Apr 1989
7610 COLORVIEW SLAVE SCOPE
K890481 · Marquette Electronics, Inc. · Mar 1989
PATIENT MONITOR MODEL 703
K884662 · Ivy Biomedical Systems, Inc. · Feb 1989
EXCALIBUR CONTROLLER (WORK LOAD PROGRAMMER)
K883402 · Quinton, Inc. · Jan 1989
FUKUDA DENSHI MODEL FX-1201
K884992 · Fukuda Denshi USA, Inc. · Jan 1989