Cleared Traditional

K972020 - OSCILLOMATE NON-INVASIVE BLOOD PRESSURE MONITOR

K972020 is an FDA 510(k) clearance for OSCILLOMATE NON-INVASIVE BLOOD PRESSURE..., manufactured by Cas Medical Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DXW cleared through the Traditional 510(k) pathway after a 337-day FDA review.

K972020 · Cas Medical Systems, Inc. · Cardiovascular device
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May 1998
Decision
337d
Days
Class 2
Risk

K972020 is an FDA 510(k) clearance for the OSCILLOMATE NON-INVASIVE BLOOD PRESSURE MONITOR. Classified as System, Phonocatheter, Intracavitary (product code DXW), Class II - Special Controls.

Submitted by Cas Medical Systems, Inc. (Branford, US). The FDA issued a Cleared decision on May 5, 1998 after a review of 337 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1270 - 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 Cas Medical Systems, Inc. devices

FDA 510(k) Submission Details - K972020

510(k) Number K972020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1997
Decision Date May 05, 1998
Days to Decision 337 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
212d slower than avg
Panel avg: 125d · This submission: 337d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXW Device Classification - Class 2, Special Controls

Product Code DXW System, Phonocatheter, Intracavitary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1270
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.