Cleared Traditional

K061737 - LOSS OF RESISTANCE SYRINGE

K061737 is an FDA 510(k) clearance for LOSS OF RESISTANCE SYRINGE, manufactured by Robert Busse & Co., Inc.. The device is a Class 2 Anesthesiology device with product code CAZ cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K061737 · Robert Busse & Co., Inc. · Anesthesiology device
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Dec 2006
Decision
181d
Days
Class 2
Risk

K061737 is an FDA 510(k) clearance for the LOSS OF RESISTANCE SYRINGE. Classified as Anesthesia Conduction Kit (product code CAZ), Class II - Special Controls.

Submitted by Robert Busse & Co., Inc. (Hauppauge, US). The FDA issued a Cleared decision on December 18, 2006 after a review of 181 days - an extended review cycle.

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 Robert Busse & Co., Inc. devices

FDA 510(k) Submission Details - K061737

510(k) Number K061737 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2006
Decision Date December 18, 2006
Days to Decision 181 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 140d · This submission: 181d
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 99
Devices cleared under the same product code (CAZ) and FDA review panel - the closest regulatory comparables to K061737.
PAJUNKS EPILONG SET PEDIATRIC
K062902 · PAJUNK GmbH Medizintechnologie · Jun 2007
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
EPISPIN, EPISPIN II SAFETY, EPISPIN II, EPISPIN I, EPISPIN IV
K060563 · Pajunk GmbH · Jun 2006
UNIPLEX NANOLINE CANNULA, PLEXOLONG NANOLINE SET, STIMULONG NANOLINE SET
K053283 · Pajunk GmbH · Jan 2006