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RxPeakFlow

by Noble Marketing

510(k) K101380

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 NumberK101380 Date13 Sep 2010ClearedStatusActive

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  • Withdrawn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, 1 Oct 2026

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

The RxPeakFlow is a peak flow meter for spirometry, classified as a Class II medical device under regulation number 21 CFR 868.1860. It is designed to measure peak expiratory flow rate as part of pulmonary function assessment.

The device was submitted for FDA 510(k) premarket notification by Noble Marketing under K101380 and received a substantially equivalent determination on September 13, 2010. It is supplied as a non-sterile, reusable device intended for use in clinical settings such as anesthesiology, with no indication of single-use designation or MRI safety specifications in the provided data.

Other devices from Noble Marketing

Questions

AI-generated answers, 1 Oct 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 RxPeakFlow used for?

    The RxPeakFlow is designed to measure peak expiratory flow rate as part of pulmonary function assessment, helping clinicians evaluate lung function in patients during spirometry testing.

  • Is the RxPeakFlow sterile or single-use?

    The RxPeakFlow is supplied as a non-sterile, reusable device, meaning it is intended for multiple uses after proper cleaning and is not provided in a sterile condition.

  • In which clinical setting is the RxPeakFlow intended to be used?

    The device is intended for use in clinical settings such as anesthesiology, where pulmonary function assessment is needed, based on its classification and submission details.

  • What regulatory pathway was used for the RxPeakFlow?

    The RxPeakFlow received a substantially equivalent determination through the FDA 510(k) premarket notification process under submission K101380, cleared on September 13, 2010.

  • Who manufactures the RxPeakFlow and where are they located?

    The RxPeakFlow is manufactured by Noble Marketing, located at 11460 N. Meridian St., Suite 150, Carmel, IN 46032, United States.