Cleared Traditional

K980879 - OSCILLOMATE NIBP / SP02 EMS MONITOR

K980879 is an FDA 510(k) clearance for OSCILLOMATE NIBP / SP02 EMS MONITOR, manufactured by Cas Medical Systems, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K980879 · Cas Medical Systems, Inc. · Anesthesiology device
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Jul 1998
Decision
129d
Days
Class 2
Risk

K980879 is an FDA 510(k) clearance for the OSCILLOMATE NIBP / SP02 EMS MONITOR. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Cas Medical Systems, Inc. (Branford, US). The FDA issued a Cleared decision on July 16, 1998 after a review of 129 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - the FDA anesthesiology and respiratory device 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Cas Medical Systems, Inc. devices

FDA 510(k) Submission Details - K980879

510(k) Number K980879 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1998
Decision Date July 16, 1998
Days to Decision 129 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 140d · This submission: 129d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQA Device Classification - Class 2, Special Controls

Product Code DQA Oximeter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2700
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - DQA Oximeter

All 577
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K980879.
MTEK-1000
K982405 · Magna Advanced Technologies, Inc. · Sep 1998
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AUTOCORR PLUS
K981939 · Bci Intl., Inc. · Aug 1998
NIHON KOHDEN TL-101T, TL-120T AND TL-121T SPO2 PROBES AND ACCESSORIES
K974292 · Nihon Kohden America, Inc. · Jun 1998
E100 SERIES SPO2 SENSORS
K970098 · Epic Medical Equipment Services, Inc. · Apr 1998
APEX OXIMETER
K980299 · Marquette Medical Systems, Inc. · Apr 1998