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Iradimed 1171

by Iradimed Corporation

Iradimed 1171 is a Class II device made by Iradimed Corporation, cleared under FDA 510(k) K172200 on 25 Oct 2017 (1 earlier submission) and listed in FDA GUDID since 17 Nov 2017 (UDI-DI 00856038001683), 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

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00856038001683 UDI-DI Date17 Nov 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK172200 Date25 Oct 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K172200 decided 25 Oct 2017 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00856038001683 listed 17 Nov 2017 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

5 dated events

  1. Cleared FDA 510(k) K090087
  2. Recall initiated FDA recalls Z-1874-2013
  3. Cleared FDA 510(k) K172200
  4. Listed FDA GUDID 00856038001683
  5. 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  • Withdrawn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
Pulse oximeter probe, reusable
Model / Ref / Catalog
1171
Primary DI / UDI-DI
00856038001683
510(k) Number
FDA product code
MWI, FRN
GMDN term
Pulse oximeter probe, reusable
Device class
Class II
Regulation number
870.2300, 880.5725
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Related devices

Category: Pulse oximeter probe, reusable

Cleared under the same submission (K090087)

and 6 more cleared under K090087

Cleared under the same submission (K172200)

and 8 more cleared under K172200

Similar devices in this category

Other devices filed under Pulse oximeter probe, reusable.

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
  • Lot / batch number
Other properties (13, all answered No)