Cleared Traditional

K983717 - BP-TEL TRANS-TELEPHONIC BLOOD PRESSURE ...

K983717 is the FDA 510(k) clearance for BP-TEL TRANS-TELEPHONIC BLOOD PRESSURE ... by Aerotel Medical Systems (1998) , Ltd.. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Traditional 510(k) pathway after a 330-day FDA review.

K983717 · Aerotel Medical Systems (1998) , Ltd. · Cardiovascular device
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Sep 1999
Decision
330d
Days
Class 2
Risk

K983717 is an FDA 510(k) clearance for the BP-TEL TRANS-TELEPHONIC BLOOD PRESSURE MEASUREMENT SYSTEM. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Aerotel Medical Systems (1998) , Ltd. (Holon, IL). The FDA issued a Cleared decision on September 16, 1999 after a review of 330 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Aerotel Medical Systems (1998) , Ltd. devices

Submission Details

510(k) Number K983717 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1998
Decision Date September 16, 1999
Days to Decision 330 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
205d slower than avg
Panel avg: 125d · This submission: 330d
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 520
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