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Epidural Anesthesia Tray

by Omnis Surgical, Inc.

510(k) K854518

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK854518 Date23 Dec 1985ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
CAZ
Device Class
Class II
Regulation
21 CFR Part 868.5140
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

An Epidural Anesthesia Tray is an anesthesia conduction kit used in anesthesiology. It is a Class II medical device.

The device received FDA 510(k) clearance under K-number K854518 on December 23, 1985, and is substantially equivalent to a predicate device. It is manufactured by Omnis Surgical, Inc. and assigned product code CAZ.

Other devices from Omnis Surgical, Inc.

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Epidural Anesthesia Tray used for?

    The Epidural Anesthesia Tray is an anesthesia conduction kit used in anesthesiology to facilitate epidural anesthesia procedures, providing the necessary components for delivering anesthetic agents into the epidural space for pain management during surgery or labor.

  • How is the Epidural Anesthesia Tray supplied and is it sterile?

    The Epidural Anesthesia Tray is supplied as a sterile, single-use kit containing all necessary components for epidural anesthesia, ensuring infection control and eliminating the need for reprocessing between uses.

  • What regulatory pathway was used for the Epidural Anesthesia Tray?

    The Epidural Anesthesia Tray received FDA 510(k) clearance under K-number K854518 on December 23, 1985, demonstrating substantial equivalence to a legally marketed predicate device under the traditional review pathway.