Apnea Alarm for Adult-Pediatric & Neon

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

510(k) Number

K831601 ↗

FDA Product Code

BZQ

Device Class

Class II

Regulation

21 CFR Part 868.2375

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Wedge Pressure Catheter

  Class II

  FDA 510(k) K830604 Active Cleared 18 Jul 1983

• Anesthesia/Respiratory Disconnect -

  Class II

  FDA 510(k) K831650 Active Cleared 12 Sep 1983

• Pediatric Anesthesia Mask W/Pacifier/Ring Assembly

  Class I

  FDA 510(k) K850263 Active Cleared 25 Mar 1985

• Central Venous Catheter

  Class II

  FDA 510(k) K823351 Active Cleared 9 Dec 1982

• Sterile Biopsy Needles

  Not classified

  FDA 510(k) K853559 Active Cleared 11 Sep 1985

• What is the apnea alarm for adult-pediatric & neon used for?

  The device is intended to measure or monitor a patient's respiratory rate and provide an audible or visible alarm when the respiratory rate, averaged over time, falls outside operator-settable alarm limits. It is used in clinical settings to detect abnormal breathing patterns in adult, pediatric, and neonatal patients.

• How is the apnea alarm supplied and is it reusable?

  The device data does not specify whether the apnea alarm is supplied sterile, single-use, or reusable. Information about its physical form, components, or reusability is not included in the provided device data, so no determination can be made about its supply condition or reuse status.

• What sizes or models are available for the apnea alarm?

  The device data does not list any specific sizes, models, or reference numbers beyond the device name and K-number. No variations in size, configuration, or model designations are mentioned, so it is not possible to identify distinct sizes or models from the provided information.

• What are the storage requirements for the apnea alarm?

  Storage conditions are not specified in the device data. No information regarding temperature, humidity, or environmental storage limits is provided, so specific storage requirements cannot be determined from the available details.

• What regulatory pathway was used for the apnea alarm?

  The device received FDA 510(k) clearance under number K831601 on September 26, 1983, and is classified as a Class II medical device under product code BZQ. It was determined to be substantially equivalent to a legally marketed device through a traditional 510(k) submission.