Cleared Traditional

K051666 - GAV - GENERAL ANAESTHETIC VAPORIZER

K051666 is an FDA 510(k) clearance for GAV - GENERAL ANAESTHETIC VAPORIZER, manufactured by General Anaesthetic Services Limited. The device is a Class 2 Anesthesiology device with product code CAD cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K051666 · General Anaesthetic Services Limited · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2005
Decision
62d
Days
Class 2
Risk

K051666 is an FDA 510(k) clearance for the GAV - GENERAL ANAESTHETIC VAPORIZER. Classified as Vaporizer, Anesthesia, Non-heated (product code CAD), Class II - Special Controls.

Submitted by General Anaesthetic Services Limited (Keighley, West Yorkshire, GB). The FDA issued a Cleared decision on August 23, 2005 after a review of 62 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5880 - 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.

FDA 510(k) Submission Details - K051666

510(k) Number K051666 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2005
Decision Date August 23, 2005
Days to Decision 62 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 140d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

CAD Device Classification - Class 2, Special Controls

Product Code CAD Vaporizer, Anesthesia, Non-heated
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5880
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 Consultant

Regulatory Technology Services, LLC

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - CAD Vaporizer, Anesthesia, Non-heated

All 41
Devices cleared under the same product code (CAD) and FDA review panel - the closest regulatory comparables to K051666.
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DELTA T
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