Cleared Traditional

K872355 - COLIN'S MODEL APBM-630 AND QUINTON'S MODEL 470

K872355 is an FDA 510(k) clearance for COLIN'S MODEL APBM-630 AND QUINTON'S MO..., manufactured by Colin Medical Instruments Corp.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K872355 · Colin Medical Instruments Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1987
Decision
89d
Days
Class 2
Risk

K872355 is an FDA 510(k) clearance for the COLIN'S MODEL APBM-630 AND QUINTON'S MODEL 470. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Colin Medical Instruments Corp. (Washington, US). The FDA issued a Cleared decision on September 15, 1987 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - 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.

View all Colin Medical Instruments Corp. devices

FDA 510(k) Submission Details - K872355

510(k) Number K872355 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1987
Decision Date September 15, 1987
Days to Decision 89 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 125d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXN Device Classification - Class 2, Special Controls

Product Code DXN System, Measurement, Blood-pressure, Non-invasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1130
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 - DXN System, Measurement, Blood-pressure, Non-invasive

All 768
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K872355.
VITAL SYSTEM
K880351 · Pace Tech, Inc. · Mar 1988
NON-INVASIVE BLOOD PRESSURE MODULE
K875265 · Ppg Industries, Inc. · Feb 1988
DINAMAP VITAL SIGNS MONITOR, MODEL 8100T
K874378 · Critikon Company, LLC · Dec 1987
TAKEDA MEDICAL DIGITAL SPHYGMOMANOMETER/ UA-741
K872629 · A&D Engineering, Inc. · Sep 1987
VITALNET(TM) SYSTEM (DINAMAP(TM), MODEL 2200)
K871418 · Critikon Company, LLC · Jul 1987
MODIFIED SPHYGMOMED NON-INVASIVE BLOOD PRES. MONIT
K871886 · Draeger Medical, Inc. · Jul 1987