Cleared Traditional

K983500 - PRO2 CHECK OXYGEN INDICATOR

K983500 is an FDA 510(k) clearance for PRO2 CHECK OXYGEN INDICATOR, manufactured by Medical Technology Specialists, Inc.. The device is a Class 2 Anesthesiology device with product code CCL cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K983500 · Medical Technology Specialists, Inc. · Anesthesiology device
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Mar 1999
Decision
162d
Days
Class 2
Risk

K983500 is an FDA 510(k) clearance for the PRO2 CHECK OXYGEN INDICATOR. Classified as Analyzer, Gas, Oxygen, Gaseous-phase (product code CCL), Class II - Special Controls.

Submitted by Medical Technology Specialists, Inc. (Richmond, US). The FDA issued a Cleared decision on March 17, 1999 after a review of 162 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1720 - 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 Medical Technology Specialists, Inc. devices

FDA 510(k) Submission Details - K983500

510(k) Number K983500 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1998
Decision Date March 17, 1999
Days to Decision 162 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 140d · This submission: 162d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CCL Device Classification - Class 2, Special Controls

Product Code CCL Analyzer, Gas, Oxygen, Gaseous-phase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1720
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 - CCL Analyzer, Gas, Oxygen, Gaseous-phase

All 63
Devices cleared under the same product code (CCL) and FDA review panel - the closest regulatory comparables to K983500.
TED 60T OXYGEN ANALYZER
K990457 · Teledyne Electronic Technologies · Nov 1999
SIEMENS FIO2 SENSOR
K991884 · Siemens Medical Solutions USA, Inc. · Nov 1999
INVACARE CHECK O2 PLUS CONCENTRATOR ANALYZER (CHECK O2 PLUS)
K984295 · Invacare Corp. · Jul 1999
HP ANESTHESIA GAS MONITOR (WATERTRAP), MODEL A02
K982619 · Hewlett-Packard Co. · Aug 1998
MODEL 02 OXYGEN ANALYZER
K971084 · Oxigraf, Inc. · Jul 1998
VACU*MED GOLD EDITION OXYGEN GAS ANALYZER
K973545 · Vacumed, Div. of Vacumetrics, Inc. · May 1998