Cleared Traditional

K001095 - OXYGEN SENSORS, MODELS CIR, C2R, R13, R15, RI7MED, R22MED, R23, R24MED, R29MED, T1, T2,T4, T7 & UFO130 (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
52d faster than avg
Panel avg: 139d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.