Medex MX20115

by ICU Medical, Inc.

Medex MX20115 is a Class II device made by ICU Medical, Inc., cleared under FDA 510(k) K952160 on 21 Sep 1995 and listed in FDA GUDID since 3 Jan 2017 (UDI-DI 10351688509765), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number10351688509765 UDI-DI	Date3 Jan 2017Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK952160	Date21 Sep 1995Decided	StatusActive

Official records

AccessGUDID record UDI-DI 10351688509765
FDA 510(k) database 510(k) number K952160

Across registries

2 registries list this device

FDA 510(k) K952160 decided 21 Sep 1995 Active
FDA GUDID UDI-DI 10351688509765 listed 3 Jan 2017 Listed

Timeline

2 dated events

21 Sep 1995 Cleared FDA 510(k) K952160
3 Jan 2017 Listed FDA GUDID 10351688509765

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Medex
Generic name: Luer/Luer linear connector, single-use
Model / reference: MX20115

Primary DI / UDI-DI: 10351688509765
510(k) Number: K952160
FDA product code: FPA
GMDN term: Luer/Luer linear connector, single-use

Device class: Class II
Regulation number: 880.5440
GUDID distribution status: In Commercial Distribution

Sterilisation method: Ethylene Oxide

Similar devices in this category

Other devices filed under Luer/Luer linear connector, single-use.

Other devices from ICU Medical, Inc.

See all devices from ICU Medical, Inc. →

Properties

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

Other properties (9, all answered No)