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Fenom Pro Nitric Oxide Test

by Spirosure, Inc.

510(k) K182874

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK182874 Date13 Feb 2019ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1284-2021 FDA Class II initiated 26 Feb 2021

    Erroneously high FeNO levels which may contribute to premature discontinuation of effective asthma treatment and persistent underlying disease. Two issues affecting the FeNO readings: 1) Drift in the calibration gases and 2) Software error. Each of these issues can cause FeNO scores/results to be erroneously high.

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  • Withdrawn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
MXA
Device Class
Class II
Regulation
21 CFR Part 862.3080
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent