Koios Medical 2.x

by Koios Medical, Inc.

Koios Medical 2.x is a Class II device made by Koios Medical, Inc., cleared under FDA 510(k) K190442 on 3 Jul 2019 and listed in FDA GUDID since 23 Mar 2020 (UDI-DI 00860002545707), active as of 22 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 22 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00860002545707 UDI-DI	Date23 Mar 2020Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK190442	Date3 Jul 2019Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00860002545707
FDA 510(k) database 510(k) number K190442

Across registries

2 registries list this device

FDA 510(k) K190442 decided 3 Jul 2019 Active
FDA GUDID UDI-DI 00860002545707 listed 23 Mar 2020 Listed

Timeline

2 dated events

3 Jul 2019 Cleared FDA 510(k) K190442
23 Mar 2020 Listed FDA GUDID 00860002545707

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Koios Medical
Generic name: Ultrasound imaging system application software
Model / reference: 2.x

Primary DI / UDI-DI: 00860002545707
510(k) Number: K190442
FDA product code: LLZ, POK
GMDN term: Ultrasound imaging system application software

Device class: Class II
Regulation number: 892.2050, 892.2060
GUDID distribution status: In Commercial Distribution

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See all devices from Koios Medical, Inc. →

Properties

Prescription use
Lot / batch number

Other properties (13, all answered No)