Cleared Traditional

K901392 - BP50 BLOOD PRESSURE AND PULSE MONITOR

K901392 is an FDA 510(k) clearance for BP50 BLOOD PRESSURE AND PULSE MONITOR, manufactured by Pulse Time Products, Ltd.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K901392

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.

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 915
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K901392.
HP MODEL M1008B, NONINVASIVE BLOOD PRESSURE MODULE
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K903222 · Biochem International, Inc. · Sep 1990
FUKUDA DENSHI MODEL HJ-310
K901889 · Fukuda Denshi USA, Inc. · Jul 1990
ESCORT NON-INVASIVE BLOOD PRESSURE OPTION
K896958 · Medical Data Electronics · Mar 1990
SUPERMON NEONATAL NON-INVASIVE BLOOD PRESS. 7283
K882955 · Kontron Instruments, Inc. · Jan 1990