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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 114
Devices cleared under the same product code (CCL) and FDA review panel - the closest regulatory comparables to K000700.
'ALL 2000' % OXYGEN ANALYZER
K002382 · Analytical Industries, Inc. · Mar 2001
100 SERIES OXYGEN ANALYZER, MODELS 1000-E AND 1000-I
K010382 · Sensidyne, Inc. · Mar 2001
M-XX OXYGEN SENSORS
K002384 · International Business Strategies · Dec 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 200T7 OXYGEN MONITOR
K990403 · Teledyne Electronic Technologies · Feb 2000
TED 60T OXYGEN ANALYZER
K990457 · Teledyne Electronic Technologies · Nov 1999
K000700 · SENSIDYNE OXYGEN ANALYZER & SENSIDYNE OXYGEN MONITOR
Download PDF FDA Summary Sensidyne, Inc.