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Medline MDSDUO200D3

by Medline Industries, Inc.

Medline MDSDUO200D3 is a Class II device made by Medline Industries, Inc., cleared under FDA 510(k) K090465 on 8 Apr 2009 and listed in FDA GUDID since 12 Jan 2026 (UDI-DI 10197344169962), 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) K090465

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 Number10197344169962 UDI-DI Date12 Jan 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK090465 Date8 Apr 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K090465 decided 8 Apr 2009 Active
  • FDA GUDID UDI-DI 10197344169962 listed 12 Jan 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K090465
  2. Listed FDA GUDID 10197344169962

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Medline
Generic name
Noninvasive vascular ultrasound system probe
Model / Ref / Catalog
MDSDUO200D3
Primary DI / UDI-DI
10197344169962
510(k) Number
FDA product code
ITX
GMDN term
Noninvasive vascular ultrasound system probe
Device class
Class II
Regulation number
892.1570
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K090465)

and 8 more cleared under K090465

Similar devices

Other devices filed under FDA product code ITX (Transducer, ultrasonic, diagnostic).

Other devices from Medline Industries, Inc.

See all devices from Medline Industries, Inc. →

Properties

  • Prescription use
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)