Cleared Traditional

OSCILLOMATE NON-INVASIVE BLOOD PRESSURE MONITOR (K972020) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K972020 · Cas Medical Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
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.

Device Classification

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.