Cleared Special

K010382 - 100 SERIES OXYGEN ANALYZER, MODELS 1000-E AND 1000-I

K010382 is an FDA 510(k) clearance for 100 SERIES OXYGEN ANALYZER, manufactured by Sensidyne, Inc.. The device is a Class 2 Anesthesiology device with product code CCL cleared through the Special 510(k) pathway after a 21-day FDA review.

K010382 · Sensidyne, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
21d
Days
Class 2
Risk

K010382 is an FDA 510(k) clearance for the 100 SERIES OXYGEN ANALYZER, MODELS 1000-E AND 1000-I. Classified as Analyzer, Gas, Oxygen, Gaseous-phase (product code CCL), Class II - Special Controls.

Submitted by Sensidyne, Inc. (Clearwater, US). The FDA issued a Cleared decision on March 1, 2001 after a review of 21 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Sensidyne, Inc. devices

FDA 510(k) Submission Details - K010382

510(k) Number K010382 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2001
Decision Date March 01, 2001
Days to Decision 21 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 140d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

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 65
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