Cleared Special

K061102 - PRIMA ANAESTHESIA MACHINE

K061102 is an FDA 510(k) clearance for PRIMA ANAESTHESIA MACHINE, manufactured by Penlon , Ltd.. The device is a Class 2 Anesthesiology device with product code BSZ cleared through the Special 510(k) pathway after a 100-day FDA review.

K061102 · Penlon , Ltd. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
100d
Days
Class 2
Risk

K061102 is an FDA 510(k) clearance for the PRIMA ANAESTHESIA MACHINE. Classified as Gas-machine, Anesthesia (product code BSZ), Class II - Special Controls.

Submitted by Penlon , Ltd. (Barton Lane, Abingdon, GB). The FDA issued a Cleared decision on July 28, 2006 after a review of 100 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5160 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K061102

510(k) Number K061102 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2006
Decision Date July 28, 2006
Days to Decision 100 days
Submission Type Special
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
40d faster than avg
Panel avg: 140d · This submission: 100d
Pathway characteristics
Modification to existing cleared device.

BSZ Device Classification - Class 2, Special Controls

Product Code BSZ Gas-machine, Anesthesia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5160
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 - BSZ Gas-machine, Anesthesia

All 158
Devices cleared under the same product code (BSZ) and FDA review panel - the closest regulatory comparables to K061102.
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K061609 · Datex-Ohmeda, Inc. · Jun 2006
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K060193 · Oceanic Medical Products, Inc. · Apr 2006
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K052335 · Accutron, Inc. · Nov 2005