Bci, Inc.: FDA clearances and approvals
Bci, Inc. has 13 FDA 510(k) clearances (first 1979, latest 2003), across 6 product codes in 4 review panels. Median 510(k) review time: 90 days.
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 | 7 | 7 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 2 | 2 |
| DPS | Electrocardiograph | 1 | 1 |
| EYN | Tray, Irrigation, Sterile | 1 | 1 |
| FMI | Needle, Hypodermic, Single Lumen | 1 | 1 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 1 | 1 |
Review panels
Most recent Bci, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K030407 | ADVISOR, MODEL 9200 | CCK | 2003-08-19 | 193 |
| K031742 | BCI 6004 NIBP MONITOR WITH NELLCOR PULSE OXIMETER | DQA | 2003-08-18 | 75 |
| K020739 | BCI 3178 PEDIATRIC PULSE OXIMETRY SENSOR | DQA | 2002-06-03 | 89 |
| K020350 | BCI 3180 PULSE OXIMETER | DQA | 2002-04-30 | 85 |
| K013862 | BCI 1621 OXIMETRY DATA MANAGEMENT PROGRAM | DQA | 2002-02-21 | 92 |
| K013171 | 3420 DIGIT PULSE OXIMETER, MODEL 3420 | DQA | 2002-01-03 | 101 |
| K011156 | BCI 3403 SLEEP SCREENING PULSE OXIMETER | DQA | 2001-06-14 | 59 |
| K010770 | BCI ADVISOR VITAL SIGNS MONITOR (9200) | MWI | 2001-06-12 | 90 |
| K011177 | BCI ADVISOR VITAL SIGNS MONITOR (9200) | DPS | 2001-05-23 | 36 |
| K001770 | BCI M4529A OEM DIGITAL HANDHELD OXIMETER, MODEL M4529A | DQA | 2000-07-05 | 23 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Bci, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Bci, Inc. have?
Bci, Inc. has 13 FDA 510(k) clearances (first 1979, latest 2003), across 6 product codes in 4 review panels.
How long does FDA take to clear Bci, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Bci, Inc.'s cleared 510(k)s is 90 days.
What devices does Bci, Inc. make?
Its most frequent FDA product codes are DQA (Oximeter, 7); CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, 2); DPS (Electrocardiograph, 1).
Has Bci, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Bci, Inc. Related entities may recall under other names.
Next steps
- See all 13 Bci, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DQA, Bci, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.