Cleared Traditional

K890876 - BP-8800 BLOOD PRESSURE MONITOR

K890876 is an FDA 510(k) clearance for BP-8800 BLOOD PRESSURE MONITOR, manufactured by Colin Medical Instruments Corp.. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K890876 · Colin Medical Instruments Corp. · Cardiovascular device
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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

FDA 510(k) Submission Details - K890876

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.

DRT Device Classification - Class 2, Special Controls

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 213
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K890876.
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TYPE PDU/CDU 9040 (SYSTEM ATHENA)
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HEALTHDYNE'S APNEA/HEART MONITOR, MODEL 900S
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