Cleared Traditional

K922668 - PILOT MODEL 9200 BLOOD PRESSURE MEASUREMENT SYSTEM

K922668 is an FDA 510(k) clearance for PILOT MODEL 9200 BLOOD PRESSURE MEASURE..., manufactured by Colin Medical Instruments Corp.. The device is a Class 2 Cardiovascular device with product code MHX cleared through the Traditional 510(k) pathway after a 1700-day FDA review.

K922668 · Colin Medical Instruments Corp. · Cardiovascular device
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Jan 1997
Decision
1700d
Days
Class 2
Risk

K922668 is an FDA 510(k) clearance for the PILOT MODEL 9200 BLOOD PRESSURE MEASUREMENT SYSTEM. Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by Colin Medical Instruments Corp. (San Antonio, US). The FDA issued a Cleared decision on January 29, 1997 after a review of 1700 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Colin Medical Instruments Corp. devices

FDA 510(k) Submission Details - K922668

510(k) Number K922668 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1992
Decision Date January 29, 1997
Days to Decision 1700 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1575d slower than avg
Panel avg: 125d · This submission: 1700d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MHX Device Classification - Class 2, Special Controls

Product Code MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
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 - MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

All 387
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