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Bci 1148

by ICU Medical, Inc.

Bci 1148 is an angiography kit (FDA Class II; FDA product code CCK, Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase) made by ICU Medical, Inc., cleared under FDA 510(k) K991086 on 9 Jun 1999 and listed in FDA GUDID since 13 Oct 2016 (UDI-DI 35019517053641), active as of 23 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K991086

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 Number35019517053641 UDI-DI Date13 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK991086 Date9 Jun 1999DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K991086 decided 9 Jun 1999 Active
  • FDA GUDID UDI-DI 35019517053641 listed 13 Oct 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-0920-2010 FDA Unclassified (pre-2012) initiated 15 Jan 2010

    Smiths Medical is conducting a voluntary recall of a limited number of medical device AC power cords, manufactured by Electri-Cord Manufacturing Co., for use with BCI 3180 Pulse Oximeter(Human), 9200 Advisor Vital Signs Monitor(Human or Veterinary), 8400 Capnocheck II Capnometer(Human or Veterinary) and V6400 Invasive Pressure Monitor (Veterinary). The affected Electri-Cord AC power cords are eq

Timeline

3 dated events

  1. Cleared FDA 510(k) K991086
  2. Recall initiated FDA recalls Z-0920-2010
  3. Listed FDA GUDID 35019517053641

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  • Withdrawn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
Angiography kit
Model / reference
1148
Primary DI / UDI-DI
35019517053641
510(k) Number
FDA product code
CCK
GMDN term
Angiography kit
Device class
Class II
Regulation number
868.1400
GUDID distribution status
In Commercial Distribution

Related devices

Category: Angiography kit

Cleared under the same submission (K991086)

and 3 more cleared under K991086

Similar devices in this category

Other devices filed under Angiography kit.

Other devices from ICU Medical, Inc.

See all devices from ICU Medical, Inc. →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)