Lithoclast Dt-485

by E.M.S. Electro Medical Systems S.A.

Lithoclast Dt-485 (M0068402980) is a Class II device made by E.M.S. Electro Medical Systems S.A., cleared under FDA 510(k) K182490 on 9 Oct 2018 (3 earlier submissions) and listed in FDA GUDID since 12 Mar 2018 (UDI-DI 07613353126391), 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

+3 more

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK182490	Date9 Oct 2018Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK181997	Date30 Aug 2018Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK181364	Date20 Jun 2018Decided	StatusActive
United States	GUDID listing	Number07613353126391 UDI-DI	Date12 Mar 2018Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK173234	Date10 Jan 2018Decided	StatusActive

Official records

AccessGUDID record UDI-DI 07613353126391
FDA 510(k) database 510(k) number K182490
FDA 510(k) database 510(k) number K181997
FDA 510(k) database 510(k) number K181364
FDA 510(k) database 510(k) number K173234

Across registries

2 registries list this device

FDA 510(k) K182490 decided 9 Oct 2018 Active· +3 more in the status table
FDA GUDID UDI-DI 07613353126391 listed 12 Mar 2018 Listed

Timeline

5 dated events

10 Jan 2018 Cleared FDA 510(k) K173234
12 Mar 2018 Listed FDA GUDID 07613353126391
20 Jun 2018 Cleared FDA 510(k) K181364
30 Aug 2018 Cleared FDA 510(k) K181997
9 Oct 2018 Cleared FDA 510(k) K182490

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Lithoclast
Generic name: Intracorporeal lithotripsy suction system
Model / Ref / Catalog: DT-485, M0068402980

Primary DI / UDI-DI: 07613353126391
510(k) Number: K173234
K181364
K181997
K182490
FDA product code: FEO, FFK
GMDN term: Intracorporeal lithotripsy suction system

Device class: Class II
Regulation number: 876.4480
GUDID distribution status: In Commercial Distribution

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Properties

Supplied sterile
Single use
Prescription use
Lot / batch number
Expiration date

Other properties (10, all answered No)