Cleared Traditional

K990403 - TED 200T7 OXYGEN MONITOR

K990403 is an FDA 510(k) clearance for TED 200T7 OXYGEN MONITOR, manufactured by Teledyne Electronic Technologies. The device is a Class 2 Anesthesiology device with product code CCL cleared through the Traditional 510(k) pathway after a 359-day FDA review.

K990403 · Teledyne Electronic Technologies · Anesthesiology device
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Feb 2000
Decision
359d
Days
Class 2
Risk

K990403 is an FDA 510(k) clearance for the TED 200T7 OXYGEN MONITOR. Classified as Analyzer, Gas, Oxygen, Gaseous-phase (product code CCL), Class II - Special Controls.

Submitted by Teledyne Electronic Technologies (City Of Industry, US). The FDA issued a Cleared decision on February 3, 2000 after a review of 359 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K990403

510(k) Number K990403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1999
Decision Date February 03, 2000
Days to Decision 359 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
219d slower than avg
Panel avg: 140d · This submission: 359d
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 114
Devices cleared under the same product code (CCL) and FDA review panel - the closest regulatory comparables to K990403.
M-XX OXYGEN SENSORS
K002384 · International Business Strategies · Dec 2000
SENSIDYNE OXYGEN ANALYZER & SENSIDYNE OXYGEN MONITOR
K000700 · Sensidyne, Inc. · Aug 2000
OXYGEN SENSORS, MODELS CIR, C2R, R13, R15, RI7MED, R22MED, R23, R24MED, R29MED, T1, T2,T4, T7 & UFO130
K001095 · Teledyne Analytical Instruments · Jun 2000
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
K990403 · TED 200T7 OXYGEN MONITOR
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