Cleared Traditional

K901392 - BP50 BLOOD PRESSURE AND PULSE MONITOR

K901392 is the FDA 510(k) clearance for BP50 BLOOD PRESSURE AND PULSE MONITOR by Pulse Time Products, Ltd.. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K901392 · Pulse Time Products, Ltd. · Cardiovascular device
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Aug 1990
Decision
150d
Days
Class 2
Risk

K901392 is an FDA 510(k) clearance for the BP50 BLOOD PRESSURE AND PULSE MONITOR. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Pulse Time Products, Ltd. (Chichester, W. Sussex, GB). The FDA issued a Cleared decision on August 23, 1990 after a review of 150 days - an extended review 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: 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 Pulse Time Products, Ltd. devices

Submission Details

510(k) Number K901392 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1990
Decision Date August 23, 1990
Days to Decision 150 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 125d · This submission: 150d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 536
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K901392.
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K882955 · Kontron Instruments, Inc. · Jan 1990
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K895428 · A&D Engineering, Inc. · Nov 1989