Cadd 21-6240-01

by ICU Medical, Inc.

Cadd 21-6240-01 is a Class II device made by ICU Medical, Inc., cleared under FDA 510(k) K982839 on 2 Nov 1998 and listed in FDA GUDID since 13 Oct 2016 (UDI-DI 10610586021725), 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	Number10610586021725 UDI-DI	Date13 Oct 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK982839	Date2 Nov 1998Decided	StatusActive

Official records

AccessGUDID record UDI-DI 10610586021725
FDA 510(k) database 510(k) number K982839

Across registries

2 registries list this device

FDA 510(k) K982839 decided 2 Nov 1998 Active
FDA GUDID UDI-DI 10610586021725 listed 13 Oct 2016 Listed

Timeline

2 dated events

2 Nov 1998 Cleared FDA 510(k) K982839
13 Oct 2016 Listed FDA GUDID 10610586021725

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Cadd
Generic name: Personal device holder, reusable
Model / reference: 21-6240-01

Primary DI / UDI-DI: 10610586021725
510(k) Number: K982839
FDA product code: MEA
GMDN term: Personal device holder, reusable

Device class: Class II
Regulation number: 880.5725
GUDID distribution status: In Commercial Distribution

Other devices from ICU Medical, Inc.

See all devices from ICU Medical, Inc. →

Properties

Prescription use
Lot / batch number

Other properties (13, all answered No)