Cleared Traditional

K954706 - KENDALL BLUNT TUOHY EPIDURAL NEEDLE

K954706 is an FDA 510(k) clearance for KENDALL BLUNT TUOHY EPIDURAL NEEDLE, manufactured by Kendall Healthcare Products Co. Div.Of Tyco Health. The device is a Class 2 Anesthesiology device with product code CAZ cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K954706 · Kendall Healthcare Products Co. Div.Of Tyco Health · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 1996
Decision
231d
Days
Class 2
Risk

K954706 is an FDA 510(k) clearance for the KENDALL BLUNT TUOHY EPIDURAL NEEDLE. Classified as Anesthesia Conduction Kit (product code CAZ), Class II - Special Controls.

Submitted by Kendall Healthcare Products Co. Div.Of Tyco Health (Mansfield, US). The FDA issued a Cleared decision on May 30, 1996 after a review of 231 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 Kendall Healthcare Products Co. Div.Of Tyco Health devices

FDA 510(k) Submission Details - K954706

510(k) Number K954706 FDA.gov
FDA Decision Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received October 12, 1995
Decision Date May 30, 1996
Days to Decision 231 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
91d slower than avg
Panel avg: 140d · This submission: 231d
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 136
Devices cleared under the same product code (CAZ) and FDA review panel - the closest regulatory comparables to K954706.
EPIDURAL ANESTHESIA KIT AND COMBINED SPINAL EPIDURAL ANESTHESIA KIT
K962821 · Global Medical Products, Ltd. · Nov 1996
MEDCARE REGIONAL ANETHESIA KIT
K961075 · Medcare Medical Group, Inc. · Sep 1996
MORE-L INJECTOR KIT PLUS
K960619 · Incutech, Inc. · Jun 1996
B-D DURASAFE COMBINED SPINAL EPIDURAL (CSE) TRAY
K954953 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1996
SPINAL SPECIALTIES NERVE BLOCK TRAY
K960100 · Spinal Specialties, Inc. · Apr 1996
HOLGRATH COMBINED SPINAL EPIDURAL NEEDLE SET
K954835 · Holgrath Medical Technologies, Inc. · Jan 1996