Cleared Abbreviated

K982135 - OSCILLOMATE EMS NIBP MONITOR MODEL 9001

K982135 is the FDA 510(k) clearance for OSCILLOMATE EMS NIBP MONITOR MODEL 9001 by Cas Medical Systems, Inc.. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Abbreviated 510(k) pathway after a 90-day FDA review.

K982135 · Cas Medical Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1998
Decision
90d
Days
Class 2
Risk

K982135 is an FDA 510(k) clearance for the OSCILLOMATE EMS NIBP MONITOR MODEL 9001. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Cas Medical Systems, Inc. (Branford, US). The FDA issued a Cleared decision on September 15, 1998 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - the FDA cardiovascular device oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Cas Medical Systems, Inc. devices

Submission Details

510(k) Number K982135 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1998
Decision Date September 15, 1998
Days to Decision 90 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Standards-based clearance path.

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 501
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K982135.
NIBP AND CO2 OPTIONS FOR THE PHYSIO-CONTROL LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM
K990338 · Physio-Control Corp. · Sep 1999
ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR, MODEL # 0998-00-0117-XX
K983575 · Datascope Corp. · May 1999
ADVANCED NIBP MODULE
K982641 · Johnson & Johnson Medical, Inc. · Mar 1999
RECHARGEABLE BATTERY PART NUMBER GL825-200
K974061 · Alexander Mfg. Co. · Jan 1998
NON-INVASIVE BLOOD PRESSURE (NIBP) MONITOR (MODEL 90553)
K941167 · Spacelabs Medical, Inc. · Nov 1994
DTX AND DTX PLUS DISPOSABLE PRESSURE TRANSDUCERS AND ACCESSORIES
K935782 · Ohmeda Medical · Aug 1994