Cleared Traditional

CURITY PARACERVICAL/PUDENDAL BLOCK ANES (K801724) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K801724 · The Kendal Co. · Anesthesiology device
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Aug 1980
Decision
14d
Days
Class 2
Risk

K801724 is an FDA 510(k) clearance for the CURITY PARACERVICAL/PUDENDAL BLOCK ANES. Classified as Anesthesia Conduction Kit (product code CAZ), Class II - Special Controls.

Submitted by The Kendal Co. (Mchenry, US). The FDA issued a Cleared decision on August 7, 1980 after a review of 14 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all The Kendal Co. devices

Submission Details

510(k) Number K801724 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1980
Decision Date August 07, 1980
Days to Decision 14 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
126d faster than avg
Panel avg: 140d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 26
Devices cleared under the same product code (CAZ) and FDA review panel - the closest regulatory comparables to K801724.
MEDTRONIC EPIDURAL CATHETER KIT MODEL 8716
K882394 · Medtronic Vascular · Sep 1988
AXILLARY BLOCK NEEDLE
K880970 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1988
EPIDURAL ANESTHESIA TRAY
K860833 · Travenol Laboratories, S.A. · Apr 1986
TRAY, ANESTHESIA, EPIDURAL, CONTINUOUS
K770571 · Travenol Laboratories, S.A. · Mar 1977
TRAY, STERILE DISPOSABLE ARTHROGRAM
K760249 · Travenol Laboratories, S.A. · Aug 1976