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Bci WW1020EN

by ICU Medical, Inc.

Bci WW1020EN is a Class II device made by ICU Medical, Inc., cleared under FDA 510(k) K083705 on 9 Apr 2009 and listed in FDA GUDID since 11 Oct 2016 (UDI-DI 30843418000108), 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

510(k) K083705

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number30843418000108 UDI-DI Date11 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK083705 Date9 Apr 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K083705 decided 9 Apr 2009 Active
  • FDA GUDID UDI-DI 30843418000108 listed 11 Oct 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K083705
  2. Listed FDA GUDID 30843418000108

Coverage

1 jurisdiction

United States of America
  • 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  • Withdrawn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
WW1020EN
Primary DI / UDI-DI
30843418000108
510(k) Number
FDA product code
DQA
GMDN term
Pulse oximeter, line-powered
Device class
Class II
Regulation number
870.2700
GUDID distribution status
In Commercial Distribution

Related devices

Category: Pulse oximeter, line-powered

Cleared under the same submission (K083705)

and 3 more cleared under K083705

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

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)