Cleared Special

K053283 - UNIPLEX NANOLINE CANNULA

K053283 is an FDA 510(k) clearance for UNIPLEX NANOLINE CANNULA, manufactured by Pajunk GmbH. The device is a Class 2 Anesthesiology device with product code CAZ cleared through the Special 510(k) pathway after a 48-day FDA review.

K053283 · Pajunk GmbH · Anesthesiology device
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Jan 2006
Decision
48d
Days
Class 2
Risk

K053283 is an FDA 510(k) clearance for the UNIPLEX NANOLINE CANNULA, PLEXOLONG NANOLINE SET, STIMULONG NANOLINE SET. Classified as Anesthesia Conduction Kit (product code CAZ), Class II - Special Controls.

Submitted by Pajunk GmbH (Geisingen, DE). The FDA issued a Cleared decision on January 12, 2006 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5140 - 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Pajunk GmbH devices

FDA 510(k) Submission Details - K053283

510(k) Number K053283 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2005
Decision Date January 12, 2006
Days to Decision 48 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
92d faster than avg
Panel avg: 140d · This submission: 48d
Pathway characteristics
Modification to existing cleared device.

CAZ Device Classification - Class 2, Special Controls

Product Code CAZ Anesthesia Conduction Kit
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5140
Definition This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance.
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 - CAZ Anesthesia Conduction Kit

All 96
Devices cleared under the same product code (CAZ) and FDA review panel - the closest regulatory comparables to K053283.
PAJUNKS STIMULONG TSUI-METHOD SET
K062900 · PAJUNK GmbH Medizintechnologie · Jan 2007
EPILONG KIT FOR ANESTHESIOLOGY
K060311 · PAJUNK GmbH Medizintechnologie · Jun 2006
EPISPIN, EPISPIN II SAFETY, EPISPIN II, EPISPIN I, EPISPIN IV
K060563 · Pajunk GmbH · Jun 2006
MODIFICATION TO PAJUNK STIMULONG PLUS CATHETER SETS
K043130 · Pajunk GmbH · Dec 2004
STIMULONG PLUS CATHETER SET MODEL, VARIOUS
K033018 · Pajunk GmbH · May 2004
PORTEX 24G PEDIATRIC EPIDURAL AND PERIPHERAL BLOCK ANESTHESIA CATHETER
K033080 · Portex, Inc. · Mar 2004