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Mega Continuous Epidural Anesthesia Kit

by Mega Medical, Inc.

510(k) K912445

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 NumberK912445 Date18 Oct 1991ClearedStatusActive

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  • Withdrawn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, 21 Sep 2026

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

The device is an Anesthesia Conduction Kit, as defined in the openFDA data. It is designed for the delivery of anesthetic agents via continuous epidural administration.

It is supplied as a kit and has received FDA 510(k) clearance under K912445. The device is intended for use in clinical settings by trained healthcare professionals for epidural anesthesia procedures.

Other devices from Mega Medical, Inc.

Questions

AI-generated answers, 21 Sep 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 MEGA CONTINUOUS EPIDURAL ANESTHESIA KIT used for?

    The MEGA CONTINUOUS EPIDURAL ANESTHESIA KIT is designed for the delivery of anesthetic agents via continuous epidural administration in clinical settings by trained healthcare professionals for epidural anesthesia procedures.

  • How is the MEGA CONTINUOUS EPIDURAL ANESTHESIA KIT supplied?

    The device is supplied as a kit, containing all necessary components for continuous epidural anesthesia administration, as indicated in the device description and specifications.

  • Is the MEGA CONTINUOUS EPIDURAL ANESTHESIA KIT intended for single-use or reuse?

    The device data does not specify whether the MEGA CONTINUOUS EPIDURAL ANESTHESIA KIT is intended for single-use or reuse; therefore, no determination can be made about its reusability based solely on the provided information.

  • What regulatory pathway was used for the MEGA CONTINUOUS EPIDURAL ANESTHESIA KIT?

    The MEGA CONTINUOUS EPIDURAL ANESTHESIA KIT received FDA 510(k) clearance under K912445, indicating it was found substantially equivalent to a legally marketed predicate device through the traditional 510(k) pathway.

  • What class is the MEGA CONTINUOUS EPIDURAL ANESTHESIA KIT classified as?

    According to the openFDA data in the device specifications, the MEGA CONTINUOUS EPIDURAL ANESTHESIA KIT is classified as a Class II medical device, as indicated by device_class=2.