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Model 3500 Infant Respiration & Heart Rate Monitor

by Bio-Dyne, Inc.

510(k) K864261

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 NumberK864261 Date27 Mar 1987ClearedStatusActive

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  • Withdrawn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, 25 Sep 2026

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

A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.

The Model 3500 Infant Respiration & Heart Rate Monitor received FDA 510(k) clearance K864261 on March 27, 1987, and is classified as a Class II device under regulation number 868.2375. It is supplied by Bio-Dyne, Inc. and assigned product code BZQ.

Other devices from Bio-Dyne, Inc.

Questions

AI-generated answers, 25 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 Model 3500 Infant Respiration & Heart Rate Monitor used for?

    The Model 3500 Infant Respiration & Heart Rate Monitor 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 does not include apnea monitoring functions classified under §868.2377.

  • How is the Model 3500 Infant Respiration & Heart Rate Monitor supplied and by whom?

    The Model 3500 Infant Respiration & Heart Rate Monitor is supplied by Bio-Dyne, Inc., located at 36 Higgins Dr., Milford, CT 06460, United States, as indicated in the device registration and manufacturer details.

  • What regulatory pathway was used for the Model 3500 Infant Respiration & Heart Rate Monitor?

    The Model 3500 Infant Respiration & Heart Rate Monitor received FDA 510(k) clearance under submission K864261 on March 27, 1987, and is classified as a Class II device under regulation number 868.2375 with product code BZQ.