Bci Intl., Inc.: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “Bci Intl., Inc.” (first 1994, latest 1999), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 87 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQA | Oximeter | 11 | 11 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 3 | 3 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 3 | 3 |
| DPS | Electrocardiograph | 1 | 1 |
| DQH | Cardiograph, Apex (Vibrocardiograph) | 1 | 1 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 1 | 1 |
Review panels
- Anesthesiology (14)
- Cardiovascular (6)
Most recent Bci Intl., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K991410 | 3402 HANDHELD PULSE OXIMETER | DQA | 1999-06-09 | 48 |
| K991086 | CAPNOCHECK II, MODEL 8400 | CCK | 1999-06-09 | 70 |
| K984618 | BCI MINI-TORR PLUS, MODEL 6004 | DXN | 1999-03-25 | 86 |
| K983796 | 6004 NIBP MONITOR WITH TEMPERATURE | DXN | 1999-01-22 | 87 |
| K982279 | VITAL SIGNS MONITOR; ADVISOR MODEL # BCI 9200 | MHX | 1998-09-25 | 87 |
| K981939 | AUTOCORR PLUS; 3404 OXIMETER/ECG MONITOR | DQA | 1998-08-20 | 79 |
| K980714 | BCI 3401 HANDHELD PULSE OXIMETER | DQA | 1998-03-25 | 29 |
| K974697 | REUSABLE FINGER SENSOR 3444 | DQH | 1998-03-11 | 85 |
| K970801 | BCI MODEL 6004 NIBP MONITOR (6004) | DXN | 1997-11-12 | 253 |
| K970209 | CAPNOCHECK PLUS | CCK | 1997-04-18 | 87 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Bci Intl., Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Bci Intl., Inc.?
FDA lists 20 510(k) clearances under the applicant name “Bci Intl., Inc.” (first 1994, latest 1999), across 6 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Bci Intl., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bci Intl., Inc. is 87 days.
Which FDA product codes appear under Bci Intl., Inc.?
The most frequent FDA product codes under this applicant name are DQA (Oximeter, 11); CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, 3); DXN (System, Measurement, Blood-Pressure, Non-Invasive, 3).
Next steps
- See all 20 Bci Intl., Inc. clearances with predicates and recalls
- Run predicate analysis for product code DQA, Bci Intl., Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.