Cleared Traditional

K010317 - AV 800 VENTILATOR

K010317 is an FDA 510(k) clearance for AV 800 VENTILATOR, manufactured by Penlon , Ltd.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K010317 · Penlon , Ltd. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2001
Decision
171d
Days
Class 2
Risk

K010317 is an FDA 510(k) clearance for the AV 800 VENTILATOR. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Penlon , Ltd. (Oxfordshire, GB). The FDA issued a Cleared decision on July 23, 2001 after a review of 171 days - an extended review cycle.

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.

FDA 510(k) Submission Details - K010317

510(k) Number K010317 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2001
Decision Date July 23, 2001
Days to Decision 171 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
31d slower than avg
Panel avg: 140d · This submission: 171d
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 435
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K010317.
OXYLOG 1000, MODEL 2M86840
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SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E
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VENTVIEW, MODEL 8414095
K012177 · Drager Medizintechnik GmbH · Sep 2001
IVENT 201 PORTABLE VENTILATOR
K011957 · Versamed , Ltd. · Jul 2001
SAVINA
K003068 · Drager Medizintechnik GmbH · Jun 2001
NON-INVASIVE VENTILATION NIV OPTION, MODEL 84 14 474
K010093 · Drager Medizintechnik GmbH · Jun 2001