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Inomax Ds

by Ino Therapeutics

510(k) K093922

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 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK093922 Date15 Apr 2010ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1223-2015 FDA Class II initiated 14 Jan 2015

    Potential delivery failure alarm condition. INOmax DSIR with software version 2.0.4 and a certain variant of the monitor display may trigger a delivery failure alarm when the display brightness is set to its lowest level. If this condition occurs, therapy will be interrupted.

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  • Withdrawn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
MRN
Device Class
Class II
Regulation
21 CFR Part 868.5165
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

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