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Iradimed 1133

by Iradimed Corporation

Iradimed 1133 is a Class II device made by Iradimed Corporation, cleared under FDA 510(k) K090087 on 7 Apr 2009 and listed in FDA GUDID since 25 Aug 2016 (UDI-DI 00856038001140), active as of 22 Oct 2026. 2 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

510(k) K090087

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00856038001140 UDI-DI Date25 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK090087 Date7 Apr 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K090087 decided 7 Apr 2009 Active
  • FDA GUDID UDI-DI 00856038001140 listed 25 Aug 2016 Listed

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-1310-2023 FDA Class II initiated 24 Feb 2023

    Certain Iradimed 1057 Syringe Adapter Sets, used with the MRidium MRI infusion pump, have a problem relating to a defective injection molded part which can limit the effectiveness of the syringe venting function which then can result in occlusion.

    • Terminated Z-1874-2013 FDA Class I initiated 1 Jul 2013

    The Dose Error Reduction System (DERS) can indicate an incorrect recommended value for the rate via a specific key sequence during the initial infusion setup. This can result in a risk of over-infusion or under-infusion if the infusion is started with this rate value.

Timeline

4 dated events

  1. Cleared FDA 510(k) K090087
  2. Recall initiated FDA recalls Z-1874-2013
  3. Listed FDA GUDID 00856038001140
  4. Recall initiated FDA recalls Z-1310-2023

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Iradimed
Generic name
Portable/mobile rechargeable battery pack
Model / Ref / Catalog
1133
Primary DI / UDI-DI
00856038001140
510(k) Number
FDA product code
FRN
GMDN term
Portable/mobile rechargeable battery pack
Device class
Class II
Regulation number
880.5725
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Related devices

Category: Portable/mobile rechargeable battery pack

Cleared under the same submission (K090087)

and 6 more cleared under K090087

Similar devices in this category

Other devices filed under Portable/mobile rechargeable battery pack.

Other devices from Iradimed Corporation

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    Class II

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    Class II

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    Class II

  • Iradimed 1832I

    Class II

See all devices from Iradimed Corporation →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)