Cleared Traditional

K781052 - CONTINUOUS EPIDURAL ANESTHESIA TRAY

K781052 is an FDA 510(k) clearance for CONTINUOUS EPIDURAL ANESTHESIA TRAY, manufactured by Portex, Inc.. The device is a Class 2 Anesthesiology device with product code CAZ cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K781052 · Portex, Inc. · Anesthesiology device
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Aug 1978
Decision
41d
Days
Class 2
Risk

K781052 is an FDA 510(k) clearance for the CONTINUOUS EPIDURAL ANESTHESIA TRAY. Classified as Anesthesia Conduction Kit (product code CAZ), Class II - Special Controls.

Submitted by Portex, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 2, 1978 after a review of 41 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 Portex, Inc. devices

FDA 510(k) Submission Details - K781052

510(k) Number K781052 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1978
Decision Date August 02, 1978
Days to Decision 41 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 140d · This submission: 41d
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 96
Devices cleared under the same product code (CAZ) and FDA review panel - the closest regulatory comparables to K781052.
CURITY PARACERVICAL/PUDENDAL BLOCK ANES
K801724 · The Kendal Co. · Aug 1980
POSITIVE PLACEMENT ANETHESIA KIT
K781469 · Arrow Intl., Inc. · Jan 1979
TRAY, AUXILLARY BLOCK
K782069 · Pharmaseal Div., Baxter Healthcare Corp. · Jan 1979
TRAY, ANESTHESIA, EPIDURAL, CONTINUOUS
K770571 · Travenol Laboratories, S.A. · Mar 1977
ANESTHESIA KIT, EPIDURAL BLOCK, CONTINU.
K770461 · Arrow Intl., Inc. · Mar 1977
ANESTHESIA KIT, EPIDURAL, SINGLE SHOT
K770356 · Arrow Intl., Inc. · Mar 1977