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Rondex Mask Models 9122/9111/9102/911102, Modified

by Rondex Products, Inc.

510(k) K921002

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 NumberK921002 Date6 Oct 1992ClearedStatusActive

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  • Withdrawn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
BTM
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 868.5915
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 Rondex Mask Models 9122/9111/9102/911102, Modified, is a manual emergency ventilator, also known as a resuscitator. It is designed to assist with ventilation during emergency medical procedures.

This device is classified as a Class 2 medical device and has received FDA 510(k) clearance under K921002. It is intended for use within the field of anesthesiology.

Other devices from Rondex Products, Inc.

See all devices from Rondex Products, Inc. →

Questions

AI-generated answers, 27 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 primary use of the Rondex Mask Models 9122/9111/9102/911102?

    These devices are manual emergency ventilators, also known as resuscitators, intended to assist with ventilation during emergency medical procedures within the field of anesthesiology.

  • What is the regulatory status of these resuscitator masks?

    The Rondex Mask models are classified as Class 2 medical devices and have received FDA 510(k) clearance under the number K921002.

  • Which medical specialty are these devices intended for?

    These manual ventilators are intended for use within the field of anesthesiology, as indicated by their classification under the anesthesiology advisory committee.