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Iradimed 3870

by Iradimed Corporation

Iradimed 3870 is a Class II device made by Iradimed Corporation, cleared under FDA 510(k) K242752 on 28 May 2025 and listed in FDA GUDID since 8 Oct 2026 (UDI-DI 00856038001942), active as of 23 Oct 2026.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K242752

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00856038001942 UDI-DI Date8 Oct 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK242752 Date28 May 2025DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K242752 decided 28 May 2025 Active
  • FDA GUDID UDI-DI 00856038001942 listed 8 Oct 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K242752
  2. Listed FDA GUDID 00856038001942

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  • Withdrawn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
Bedside infusion pump, single-channel
Model / reference
3870
Primary DI / UDI-DI
00856038001942
510(k) Number
FDA product code
FRN
GMDN term
Bedside infusion pump, single-channel
Device class
Class II
Regulation number
880.5725
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Other devices from Iradimed Corporation

  • Iradimed 1832SA

    Class II

  • Iradimed 1834SA-10

    Class II

  • Iradimed 1832I

    Class II

  • Iradimed 3882

    Class II

See all devices from Iradimed Corporation →

Properties

  • Serial number
  • Manufacturing date
Other properties (13, all answered No)