Cleared Traditional

K903887 - CURITY NERVE BLOCK TRAY

K903887 is an FDA 510(k) clearance for CURITY NERVE BLOCK TRAY, 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 100-day FDA review.

K903887 · Kendall Healthcare Products Co. Div.Of Tyco Health · Anesthesiology device
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Nov 1990
Decision
100d
Days
Class 2
Risk

K903887 is an FDA 510(k) clearance for the CURITY NERVE BLOCK TRAY. 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 November 30, 1990 after a review of 100 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 Kendall Healthcare Products Co. Div.Of Tyco Health devices

FDA 510(k) Submission Details - K903887

510(k) Number K903887 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 1990
Decision Date November 30, 1990
Days to Decision 100 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 140d · This submission: 100d
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 97
Devices cleared under the same product code (CAZ) and FDA review panel - the closest regulatory comparables to K903887.
B-D LOSS OF RESISTANCE SYRINGE
K925902 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1993
CURITY SPINAL ANESTHESIA TRAY
K903761 · Kendall Healthcare Products Co. Div.Of Tyco Health · Dec 1990
COSPAN CONTINUOUS SPINAL ANESTHESIA TRAY
K904101 · Kendall Healthcare Products Co. Div.Of Tyco Health · Dec 1990
CURITY PEDIATRIC CONTINUOUS CAUDAL ANESTHESIA TRAY
K902647 · Kendall Healthcare Products Co. Div.Of Tyco Health · Nov 1990
COSPAN PEDIATRIC CONTINUOUS SPINAL ANESTHESIA TRAY
K902312 · Kendall Healthcare Products Co. Div.Of Tyco Health · Jul 1990
PARACERVICAL/PUDENDAL TRAYS
K896799 · Westmark, Sterile Packing Systems, Inc. (Sps) · Apr 1990