Bci WW1018B

by ICU Medical, Inc.

Bci WW1018B is a Class II device made by ICU Medical, Inc., cleared under FDA 510(k) K083557 on 1 May 2009 and listed in FDA GUDID since 5 Dec 2019 (UDI-DI 10610586039645), 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	Number10610586039645 UDI-DI	Date5 Dec 2019Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK083557	Date1 May 2009Decided	StatusActive

Official records

AccessGUDID record UDI-DI 10610586039645
FDA 510(k) database 510(k) number K083557

Across registries

2 registries list this device

FDA 510(k) K083557 decided 1 May 2009 Active
FDA GUDID UDI-DI 10610586039645 listed 5 Dec 2019 Listed

Timeline

2 dated events

1 May 2009 Cleared FDA 510(k) K083557
5 Dec 2019 Listed FDA GUDID 10610586039645

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Bci
Generic name: Pulse oximeter, line-powered
Model / reference: WW1018B

Primary DI / UDI-DI: 10610586039645
510(k) Number: K083557
FDA product code: DQA
GMDN term: Pulse oximeter, line-powered

Device class: Class II
Regulation number: 870.2700
GUDID distribution status: In Commercial Distribution

Similar devices in this category

Other devices filed under Pulse oximeter, line-powered.

Other devices from ICU Medical, Inc.

See all devices from ICU Medical, Inc. →

Properties

Lot / batch number

Other properties (14, all answered No)