Cleared Traditional

K901514 - XR MODEL H PHYSIOLOGICAL MONITOR & RECO...

K901514 is the FDA 510(k) clearance for XR MODEL H PHYSIOLOGICAL MONITOR & RECO... by Ppg Industries, Inc.. It is a Class 2 Cardiovascular device (product code DSK) cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K901514 · Ppg Industries, Inc. · Cardiovascular device
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Nov 1990
Decision
231d
Days
Class 2
Risk

K901514 is an FDA 510(k) clearance for the XR MODEL H PHYSIOLOGICAL MONITOR & RECORDING SYS.. Classified as Computer, Blood-pressure (product code DSK), Class II - Special Controls.

Submitted by Ppg Industries, Inc. (Lenexa, US). The FDA issued a Cleared decision on November 16, 1990 after a review of 231 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1110 - 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 Ppg Industries, Inc. devices

Submission Details

510(k) Number K901514 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1990
Decision Date November 16, 1990
Days to Decision 231 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
106d slower than avg
Panel avg: 125d · This submission: 231d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DSK Computer, Blood-pressure
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1110
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 - DSK Computer, Blood-pressure

All 13
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