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Peak Flow Meter

by Projects IN Health

510(k) K770580

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 NumberK770580 Date4 Aug 1977ClearedStatusActive

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  • Withdrawn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
BZH
Device Class
Class II
Regulation
21 CFR Part 868.1860
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 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 Peak Flow Meter is a device used to measure peak expiratory flow, which is the fastest rate at which a person can exhale air from their lungs. It is a type of spirometry device, classified under the product code BZH and regulation number 868.1860. The device is substantially equivalent and has been cleared by the FDA.

The Peak Flow Meter is supplied as a single device and is intended for use in clinical settings, such as anesthesiology. It is not specified as single-use or reusable, or its MRI safety. The device has been authorized by the FDA under the 510K clearance type and has a device class of 2. It is manufactured by Projects IN Health and has a registration number and fei number associated with it.

Other devices from Projects IN Health

  • Pinwheel

    Class I

  • Meter, Flow, Peak

    Class II