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Model 6213 Remote Alarm

by Aequitron Medical, Inc.

510(k) K914424

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 NumberK914424 Date10 Sep 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  • Withdrawn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
CBK
Device Class
Class II
Regulation
21 CFR Part 868.5895
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Model 6213 Remote Alarm is a ventilator accessory designed for continuous, facility-based use in anesthesia settings. It provides remote monitoring and alarm signaling for ventilator parameters, ensuring patient safety during mechanical ventilation.

This device is intended for use in hospital or clinical environments and is classified as a Class II medical device under FDA regulations. Supplied as a reusable component, it interfaces with ventilators to alert personnel to critical changes in respiratory parameters. Authorized under FDA 510(k) clearance (K914424), it adheres to regulatory standards for anesthesia-related monitoring equipment.

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Questions

AI-generated answers, 19 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 purpose of the Model 6213 Remote Alarm in anesthesia settings?

    The Model 6213 Remote Alarm is designed to provide continuous remote monitoring and alarm signaling for ventilator parameters during mechanical ventilation in anesthesia. It alerts personnel to critical changes in respiratory parameters, helping ensure patient safety in facility-based settings like hospitals.

  • Is the Model 6213 Remote Alarm intended for single-use or reusable applications?

    The Model 6213 Remote Alarm is explicitly supplied as a reusable component, meaning it is designed for repeated use in clinical environments after proper cleaning and maintenance.

  • How was the regulatory pathway for the Model 6213 Remote Alarm determined?

    The device was authorized through the FDA’s 510(k) clearance process, specifically under a *Traditional* review route, and was determined to be *Substantially Equivalent* to a predicate device. It falls under the Class II medical device category and was reviewed by the Anesthesiology (AN) Advisory Committee.

  • What types of ventilators is the Model 6213 Remote Alarm compatible with?

    The device is compatible with a broad range of ventilators, as indicated by its FDA product code (CBK) and the extensive list of associated FEI numbers (e.g., 3000143502, 3008264065). These identifiers correspond to ventilators used in anesthesia settings, ensuring broad interoperability with common facility-based ventilators.

  • What regulatory standards does the Model 6213 Remote Alarm adhere to?

    The device adheres to FDA regulatory standards for anesthesia-related monitoring equipment, specifically under the regulation number 868.5895. It was cleared under the FDA’s 510(k) pathway, ensuring compliance with Class II device requirements for ventilator accessories.