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JLS Group Infant Monitor

by Jls Group, Inc.

510(k) K820374

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 NumberK820374 Date26 Mar 1982ClearedStatusActive

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  • Withdrawn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
BZQ
Device Class
Class II
Regulation
21 CFR Part 868.2375
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 JLS Group Infant Monitor is a medical device classified as a breathing frequency monitor, designed to measure and display the respiratory rate of infants. It provides real-time monitoring to assess ventilation and detect irregular breathing patterns, supporting clinical assessment in neonatal and pediatric care settings.

This device is intended for use in clinical environments, such as hospitals and neonatal intensive care units, and is supplied as a reusable medical instrument. It is not sterile and requires proper cleaning and maintenance between uses. The monitor adheres to FDA 510(k) clearance (K820374) under the regulatory classification BZQ, with no specific MRI safety or single-use designation noted in the data.

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 clinical settings is the JLS Group Infant Monitor intended for use in?

    The JLS Group Infant Monitor is designed for use in clinical environments such as hospitals and neonatal intensive care units (NICUs). Its primary purpose is to monitor the respiratory rate of infants in real-time, helping clinicians assess ventilation and detect irregular breathing patterns.

  • Is the JLS Group Infant Monitor a single-use or reusable device?

    The JLS Group Infant Monitor is supplied as a reusable medical instrument. Since it is not sterile, it requires proper cleaning and maintenance between uses to ensure accuracy and hygiene.

  • How is the regulatory status of the JLS Group Infant Monitor determined?

    The device holds FDA 510(k) clearance under the product code BZQ, with a decision classification of *Substantially Equivalent* to a predicate device. It was originally submitted in 1982 and cleared under the Anesthesiology Advisory Committee (AN). The clearance number is K820374, indicating it follows traditional FDA review procedures.

  • Does the JLS Group Infant Monitor come in multiple sizes or models?

    The device data lists multiple registration numbers (e.g., 3026751377, 3015455735, etc.), which may correspond to different models or configurations. However, the specifications do not explicitly detail size variations or model-specific features. For precise sizing or model details, consult the manufacturer’s documentation or contact JLS Group, Inc.