Cleared Traditional

K051222 - AV-S ANAESTHESIA VENTILATOR

K051222 is an FDA 510(k) clearance for AV-S ANAESTHESIA VENTILATOR, manufactured by Penlon Limited. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K051222 · Penlon Limited · Anesthesiology device
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Sep 2005
Decision
134d
Days
Class 2
Risk

K051222 is an FDA 510(k) clearance for the AV-S ANAESTHESIA VENTILATOR. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Penlon Limited (Oxon, GB). The FDA issued a Cleared decision on September 23, 2005 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - 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 Penlon Limited devices

FDA 510(k) Submission Details - K051222

510(k) Number K051222 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2005
Decision Date September 23, 2005
Days to Decision 134 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
6d faster than avg
Panel avg: 140d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBK Device Classification - Class 2, Special Controls

Product Code CBK Ventilator, Continuous, Facility Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5895
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 - CBK Ventilator, Continuous, Facility Use

All 327
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K051222.
NEWPORT E360 VENTILATOR
K053502 · Newport Medical Instruments, Inc. · Jan 2006
RAPHAEL COLOR
K052863 · Hamilton Medical AG · Jan 2006
GE DATEX-OHMEDA ENGSTROM CARESTATION
K051895 · Datex-Ohmeda, Inc. · Sep 2005
GE DATEX-OHMEDA CENTIVA/5 VENTILATOR
K050860 · Datex-Ohmeda, Inc. · Jun 2005
GE DATEX-OHMEDA ENGSTROM CARESTATION
K050597 · Datex-Ohmeda, Inc. · Mar 2005
GE DATEX-OHMEDA ENGSTROM CARESTATION
K041775 · Datex-Ohmeda, Inc. · Oct 2004