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Omni Express

by Infinium Medical

510(k) K103268

Omni Express is a medical device (FDA Class II; FDA product code MWI, Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)) made by Infinium Medical, cleared under FDA 510(k) K103268 on 23 Nov 2010, active as of 22 Oct 2026.

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK103268 Date23 Nov 2010ClearedStatusActive

Official records

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  • Withdrawn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
MWI
Device class
Class II
Regulation
21 CFR Part 870.2300
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K103268

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K103268
UDI-DISize and differences
Waveline EZ 8856
Avante
885600815871021920 —On the market

Similar devices

Other devices filed under FDA product code MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)).

Other devices from Infinium Medical, Inc.

See all devices from Infinium Medical, Inc. →