Cleared Special

K061102 - PRIMA ANAESTHESIA MACHINE (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K061102 · Penlon , Ltd. · Anesthesiology device
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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.

View all Penlon , Ltd. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 139d · This submission: 100d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 186
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