Cleared Traditional

OXYGEN MEDICELS, CITICELS (K041773) - FDA 510(k) Clearance

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

K041773 · City Technology Limited · Anesthesiology device
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Jul 2004
Decision
14d
Days
Class 2
Risk

K041773 is an FDA 510(k) clearance for the OXYGEN MEDICELS, CITICELS. Classified as Analyzer, Gas, Oxygen, Gaseous-phase (product code CCL), Class II - Special Controls.

Submitted by City Technology Limited (Portsmouth,Hampshire England, GB). The FDA issued a Cleared decision on July 15, 2004 after a review of 14 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 City Technology Limited devices

Submission Details

510(k) Number K041773 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2004
Decision Date July 15, 2004
Days to Decision 14 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
126d faster than avg
Panel avg: 140d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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.

Regulatory Peers - CCL Analyzer, Gas, Oxygen, Gaseous-phase

All 19
Devices cleared under the same product code (CCL) and FDA review panel - the closest regulatory comparables to K041773.
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K051092 · Ge Healthcare · May 2005
SIEMENS FIO2 SENSOR
K991884 · Siemens Medical Solutions USA, Inc. · Nov 1999
INVACARE CHECK O2 PLUS CONCENTRATOR ANALYZER (CHECK O2 PLUS)
K984295 · Invacare Corp. · Jul 1999
HP ANESTHESIA GAS MONITOR (WATERTRAP), MODEL A02
K982619 · Hewlett-Packard Co. · Aug 1998