Cleared Traditional

K941490 - BLOOD PRESSURE METER MODEL NO. BPM888

K941490 is the FDA 510(k) clearance for BLOOD PRESSURE METER MODEL NO. BPM888 by Integrated Display Technology, Ltd.. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Traditional 510(k) pathway after a 246-day FDA review.

K941490 · Integrated Display Technology, Ltd. · Cardiovascular device
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Nov 1994
Decision
246d
Days
Class 2
Risk

K941490 is an FDA 510(k) clearance for the BLOOD PRESSURE METER MODEL NO. BPM888. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Integrated Display Technology, Ltd. (Hunghom, Kowloon, HK). The FDA issued a Cleared decision on November 29, 1994 after a review of 246 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 Integrated Display Technology, Ltd. devices

Submission Details

510(k) Number K941490 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1994
Decision Date November 29, 1994
Days to Decision 246 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
121d slower than avg
Panel avg: 125d · This submission: 246d
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 538
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