510(k) Report

FDA applicant

Bci, Inc.

Waukesha, WI13 decisions1979–200347 recalls

FDA records 13 decisions for Bci, Inc. (Waukesha, WI) from 1979 to 2003: 13 510(k) clearances. Most are in product codes DQA (Oximeter) and CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase). Its devices cite 21 predicates, 3 of them its own earlier devices. 47 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Bci, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bci, Inc. since 2007.

Recalls per year

1in 2025

2007: 12008: 32010: 22015: 12017: 12025: 1
2007high 3 (2008) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Bci, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Bci, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • DQAOximeter7decisions
  • CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase2decisions
  • FMINeedle, Hypodermic, Single Lumen1decision
  • MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)1decision
  • DPSElectrocardiograph1decision
  • EYNTray, Irrigation, Sterile1decision

Whose devices does it build on?

Its devices cite 21 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 3 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K010770Bci Advisor Vital Signs Monitor (9200)Bci, Inc. · 20011cites it
  • K011156Bci 3403 Sleep Screening Pulse OximeterBci, Inc. · 20011cites it
  • K030407Advisor, Model 9200Bci, Inc. · 20031cites it
  • K011177Bci Advisor Vital Signs Monitor (9200)Bci, Inc. · 20011cites it
  • K0131713420 Digit Pulse Oximeter, Model 3420Bci, Inc. · 20021cites it
  • K941982CapnocheckBci, Inc. · 19941cites it

What has FDA decided for it lately?

  • K030407Advisor, Model 9200Bci, Inc. · 200343 recalls
  • K031742Bci 6004 Nibp Monitor with Nellcor Pulse OximeterBci, Inc. · 20031 recall
  • K020739Bci 3178 Pediatric Pulse Oximetry SensorBci, Inc. · 2002
  • K020350Bci 3180 Pulse OximeterBci, Inc. · 20022 recalls
  • K013862Bci 1621 Oximetry Data Management ProgramBci, Inc. · 2002
  • K0131713420 Digit Pulse Oximeter, Model 3420Bci, Inc. · 2002
  • K011156Bci 3403 Sleep Screening Pulse OximeterBci, Inc. · 2001
  • K010770Bci Advisor Vital Signs Monitor (9200)Bci, Inc. · 200135 recalls

All 13 as Bci, Inc. →

What has been recalled?

47 recalls linked to its devices; the latest:

  • K941982CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214Feb 14, 2025Class II
  • K030407BCI Advisor Vital Signs Monitor, Model 9200, Reorder numbers 920654235, 920654235…Nov 29, 2017Class II
  • K030407Smiths Medical, BCI Advisor Vital Signs Monitor, Product Reorder No 92M774325A.Mar 21, 2015Class II
  • K0304079200 Advisor Vital Signs Monitor uses power cord WW3005 (Electri-Cord Manufacturing Co.…Jan 15, 2010
  • K020350BCI 3180 Pulse Oximeter uses power cord WW3005 (Electri-Cord Manufacturing Co., 312 E.…Jan 15, 2010
  • K010770Smiths Medical BCI (R) Advisor (R) Vital Signs Monitor, model 9200, catalog numbers…Dec 22, 2008