510(k) Report

FDA applicant

Bci Intl., Inc.

Waukesha, WI20 decisions1994–199945 recalls

FDA records 20 decisions for Bci Intl., Inc. (Waukesha, WI) from 1994 to 1999: 20 510(k) clearances. Most are in product codes DQA (Oximeter) and CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase). Its devices cite 9 predicates, 7 of them its own earlier devices. 45 recalls are linked to its devices, 1 Class I.

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 Intl., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bci Intl., Inc. since 2007.

Recalls per year

1in 2013

2007: 22008: 22010: 12013: 1, 1 Class I
2007high 2 (2007) · low 0 (2009)2026

Class I Class II/III not classified

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

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

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Which product codes does it file in?

  • DQAOximeter11decisions
  • CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase3decisions
  • DXNSystem, Measurement, Blood-Pressure, Non-Invasive3decisions
  • DPSElectrocardiograph1decision
  • DQHCardiograph, Apex (Vibrocardiograph)1decision
  • MHXMonitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)1decision

Whose devices does it build on?

Its devices cite 9 predicates; 7 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 32 times; 7 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.

  • K9621563304 Pulse OximeterBci Intl., Inc. · 19968cite it
  • K970209Capnocheck PlusBci Intl., Inc. · 19974cite it
  • K9837966004 Nibp Monitor with TemperatureBci Intl., Inc. · 19994cite it
  • K970801Bci Model 6004 Nibp Monitor (6004)Bci Intl., Inc. · 19973cite it
  • K980714Bci 3401 Handheld Pulse OximeterBci Intl., Inc. · 19983cite it
  • K9914103402 Handheld Pulse OximeterBci Intl., Inc. · 19993cite it

What has FDA decided for it lately?

  • K991086Capnocheck II, Model 8400Bci Intl., Inc. · 19991 recall
  • K9914103402 Handheld Pulse OximeterBci Intl., Inc. · 1999
  • K984618Bci Mini-Torr Plus, Model 6004Bci Intl., Inc. · 19991 recall
  • K9837966004 Nibp Monitor with TemperatureBci Intl., Inc. · 19991 recall
  • K982279Vital Signs Monitor; Advisor Model # Bci 9200Bci Intl., Inc. · 199840 recalls
  • K981939Autocorr Plus; 3404 Oximeter/Ecg MonitorBci Intl., Inc. · 19982 recalls
  • K980714Bci 3401 Handheld Pulse OximeterBci Intl., Inc. · 1998
  • K974697Reusable Finger Sensor 3444Bci Intl., Inc. · 1998

All 20 as Bci Intl., Inc. →

What has been recalled?

45 recalls linked to its devices; the latest:

  • K970209Smiths Medical, BCI Remote Alarm Cable (Normally Open & Normally Closed), Reorder…Feb 6, 2013Class I
  • K9910868400 Capnocheck Capnometer uses power cord 8404 (Electri-Cord Manufacturing, 312 E. Main…Jan 15, 2010
  • K010770Smiths Medical BCI (R) Advisor (R) Vital Signs Monitor, model 9200, catalog numbers…Dec 22, 2008
  • K031742BCI Non Invasive Blood Pressure Monitor Product/Catalog number 6004,Apr 2, 2008
  • K981939BCI Autocorr Plus Pulse Oximeter/ECG/Respiration Monitor, Catalog Numbers, 3404001…Jul 18, 2007
  • K010770BCI Advisor Vital Signs Monitor (Model/Catalog Number: 9200)Jun 5, 2007