Cleared Traditional

K060563 - EPISPIN

K060563 is an FDA 510(k) clearance for EPISPIN, manufactured by Pajunk GmbH. The device is a Class 2 Anesthesiology device with product code CAZ cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K060563 · Pajunk GmbH · Anesthesiology device
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Jun 2006
Decision
114d
Days
Class 2
Risk

K060563 is an FDA 510(k) clearance for the EPISPIN, EPISPIN II SAFETY, EPISPIN II, EPISPIN I, EPISPIN IV. 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 June 2, 2006 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5140 - 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 Pajunk GmbH devices

FDA 510(k) Submission Details - K060563

510(k) Number K060563 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2006
Decision Date June 02, 2006
Days to Decision 114 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
26d faster than avg
Panel avg: 140d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K060563.
GLASS LOSS OF RESISTANCE SYRINGE
K063018 · Busse Hospital Disposables, Inc. · Jan 2007
PAJUNKS STIMULONG TSUI-METHOD SET
K062900 · PAJUNK GmbH Medizintechnologie · Jan 2007
EPILONG KIT FOR ANESTHESIOLOGY
K060311 · PAJUNK GmbH Medizintechnologie · Jun 2006
UNIPLEX NANOLINE CANNULA, PLEXOLONG NANOLINE SET, STIMULONG NANOLINE SET
K053283 · Pajunk GmbH · Jan 2006
MODIFICATION TO PAJUNK STIMULONG PLUS CATHETER SETS
K043130 · Pajunk GmbH · Dec 2004
STIMULONG PLUS CATHETER SET MODEL, VARIOUS
K033018 · Pajunk GmbH · May 2004