Cleared Traditional

K001095 - OXYGEN SENSORS, MODELS CIR, C2R, R13, R15, RI7MED, R22MED, R23, R24MED, R29MED, T1, T2,T4, T7 & UFO130

K001095 is an FDA 510(k) clearance for OXYGEN SENSORS, manufactured by Teledyne Analytical Instruments. The device is a Class 2 Anesthesiology device with product code CCL cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K001095 · Teledyne Analytical Instruments · Anesthesiology device
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Jun 2000
Decision
87d
Days
Class 2
Risk

K001095 is an FDA 510(k) clearance for the OXYGEN SENSORS, MODELS CIR, C2R, R13, R15, RI7MED, R22MED, R23, R24MED, R29ME.... Classified as Analyzer, Gas, Oxygen, Gaseous-phase (product code CCL), Class II - Special Controls.

Submitted by Teledyne Analytical Instruments (City Of Industry, US). The FDA issued a Cleared decision on June 30, 2000 after a review of 87 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Teledyne Analytical Instruments devices

FDA 510(k) Submission Details - K001095

510(k) Number K001095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2000
Decision Date June 30, 2000
Days to Decision 87 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 140d · This submission: 87d
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 64
Devices cleared under the same product code (CCL) and FDA review panel - the closest regulatory comparables to K001095.
ULTRAMAXO2 OXYGEN ANALYER
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K051092 · Ge Healthcare · May 2005
TED 200T7 OXYGEN MONITOR
K990403 · Teledyne Electronic Technologies · Feb 2000
TED 60T OXYGEN ANALYZER
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SIEMENS FIO2 SENSOR
K991884 · Siemens Medical Solutions USA, Inc. · Nov 1999