Cleared Special

K080804 - BUSSE PLASTIC LOR SYRINGE

K080804 is an FDA 510(k) clearance for BUSSE PLASTIC LOR SYRINGE, manufactured by Busse Hosipital Disposables. The device is a Class 2 Anesthesiology device with product code CAZ cleared through the Special 510(k) pathway after a 110-day FDA review.

K080804 · Busse Hosipital Disposables · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2008
Decision
110d
Days
Class 2
Risk

K080804 is an FDA 510(k) clearance for the BUSSE PLASTIC LOR SYRINGE. Classified as Anesthesia Conduction Kit (product code CAZ), Class II - Special Controls.

Submitted by Busse Hosipital Disposables (Hauppauge, US). The FDA issued a Cleared decision on July 9, 2008 after a review of 110 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. 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 - K080804

510(k) Number K080804 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2008
Decision Date July 09, 2008
Days to Decision 110 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 140d · This submission: 110d
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 137
Devices cleared under the same product code (CAZ) and FDA review panel - the closest regulatory comparables to K080804.
B. BRAUN CONTIPLEX CONTINUOUS NERVE BLOCK SET
K090995 · B.Braun Medical, Inc. · Aug 2009
PAJUNK'S GENERIC CONVENIENCE TRAY FOR REGIONAL ANESTHESIA: CSF
K082183 · PAJUNK GmbH Medizintechnologie · Oct 2008
PAJUNK'S GENERIC CONVENIENCE TRAY FOR REGIONAL ANESTHESIA OF THE PERIPHERAL PLEXUS: SINGLE SHOT
K082164 · PAJUNK GmbH Medizintechnologie · Oct 2008
PERIPHERAL NERVE BLOCK SUPPORT TRAY
K073187 · Life-Tech, Inc. · Apr 2008
CONTIPLEX STIM CONTINUOUS NERVE BLOCK SET
K063282 · B.Braun Medical, Inc. · Jun 2007
PAJUNKS EPILONG SET PEDIATRIC
K062902 · PAJUNK GmbH Medizintechnologie · Jun 2007