Cleared Traditional

K000700 - SENSIDYNE OXYGEN ANALYZER & SENSIDYNE OXYGEN MONITOR

K000700 is an FDA 510(k) clearance for SENSIDYNE OXYGEN ANALYZER & SENSIDYNE O..., manufactured by Sensidyne, Inc.. The device is a Class 2 Anesthesiology device with product code CCL cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K000700 · Sensidyne, Inc. · Anesthesiology device
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Aug 2000
Decision
183d
Days
Class 2
Risk

K000700 is an FDA 510(k) clearance for the SENSIDYNE OXYGEN ANALYZER & SENSIDYNE OXYGEN MONITOR. 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 August 31, 2000 after a review of 183 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 Sensidyne, Inc. devices

FDA 510(k) Submission Details - K000700

510(k) Number K000700 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2000
Decision Date August 31, 2000
Days to Decision 183 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 140d · This submission: 183d
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 65
Devices cleared under the same product code (CCL) and FDA review panel - the closest regulatory comparables to K000700.
ULTRAMAXO2 OXYGEN ANALYER
K112402 · Maxtec, LLC · Dec 2011
PRECISION OXYGEN MONITOR
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K051092 · Ge Healthcare · May 2005
TED 200T7 OXYGEN MONITOR
K990403 · Teledyne Electronic Technologies · Feb 2000
TED 60T OXYGEN ANALYZER
K990457 · Teledyne Electronic Technologies · Nov 1999
SIEMENS FIO2 SENSOR
K991884 · Siemens Medical Solutions USA, Inc. · Nov 1999