Cleared Traditional

BP-8800 BLOOD PRESSURE MONITOR (K890876) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K890876 · Colin Medical Instruments Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1989
Decision
121d
Days
Class 2
Risk

K890876 is an FDA 510(k) clearance for the BP-8800 BLOOD PRESSURE MONITOR. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Colin Medical Instruments Corp. (South Plainfield, US). The FDA issued a Cleared decision on June 22, 1989 after a review of 121 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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

Submission Details

510(k) Number K890876 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1989
Decision Date June 22, 1989
Days to Decision 121 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 125d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 - DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

All 74
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K890876.
WEP-8430A TELEMETRY CENTRAL STATION
K904696 · Nihon Kohden America, Inc. · Feb 1991
MODELS WEP-8410A AND WEP-8420A TELEMETRY CENTRAL
K901034 · Nihon Kohden America, Inc. · Apr 1990
MODEL M1175A/M1176A WITH ST SEGMENT MONITORING
K900032 · Hewlett-Packard Co. · Apr 1990
COMPANION 50 REGULATOR/FLOWMETER
K872443 · Puritan Bennett Corp. · Jul 1987
LIFESCOPE 8, OEC-8120 PORTABLE PATIENT MONITOR REC
K862463 · Nihon Kohden America, Inc. · Dec 1986
PATIENT MONITOR PB240
K853318 · Puritan Bennett Corp. · Mar 1986