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MIMOSA Pro

by Mimosa Diagnostics, Inc.

MIMOSA Pro is a Class II device made by Mimosa Diagnostics, Inc., cleared under FDA 510(k) K190334 on 1 Nov 2019 and listed in FDA GUDID since 1 Feb 2022 (UDI-DI 00627987881806), 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) K190334

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 Number00627987881806 UDI-DI Date1 Feb 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK190334 Date1 Nov 2019DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K190334 decided 1 Nov 2019 Active
  • FDA GUDID UDI-DI 00627987881806 listed 1 Feb 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K190334
  2. Listed FDA GUDID 00627987881806

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Mimosa
Generic name
Tissue saturation oximeter
Model / reference
MIMOSA Pro
Primary DI / UDI-DI
00627987881806
510(k) Number
FDA product code
MUD
GMDN term
Tissue saturation oximeter
Device class
Class II
Regulation number
870.2700
GUDID distribution status
In Commercial Distribution

Related devices

Category: Tissue saturation oximeter

Other devices from Mimosa Diagnostics, Inc.

  • MIMOSA Imager

    Class II

Properties

  • Serial number
Other properties (14, all answered No)