Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bci, Inc. · Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
175 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K030407 | ADVISOR, MODEL 9200 | Bci, Inc. | 2003-08-19 | 193 | 42 |
| K031742 | BCI 6004 NIBP MONITOR WITH NELLCOR PULSE OXIMETER | Bci, Inc. | 2003-08-18 | 75 | 1 |
| K020739 | BCI 3178 PEDIATRIC PULSE OXIMETRY SENSOR | Bci, Inc. | 2002-06-03 | 89 | 0 |
| K020350 | BCI 3180 PULSE OXIMETER | Bci, Inc. | 2002-04-30 | 85 | 2 |
| K013862 | BCI 1621 OXIMETRY DATA MANAGEMENT PROGRAM | Bci, Inc. | 2002-02-21 | 92 | 0 |
| K013171 | 3420 DIGIT PULSE OXIMETER, MODEL 3420 | Bci, Inc. | 2002-01-03 | 101 | 0 |
| K011156 | BCI 3403 SLEEP SCREENING PULSE OXIMETER | Bci, Inc. | 2001-06-14 | 59 | 0 |
| K010770 | BCI ADVISOR VITAL SIGNS MONITOR (9200) | Bci, Inc. | 2001-06-12 | 90 | 35 |
| K011177 | BCI ADVISOR VITAL SIGNS MONITOR (9200) | Bci, Inc. | 2001-05-23 | 36 | 39 |
| K001770 | BCI M4529A OEM DIGITAL HANDHELD OXIMETER, MODEL M4529A | Bci, Inc. | 2000-07-05 | 23 | 0 |
| K944121 | SHARPS CONTAINER 18 GALLON | Bci, Inc. | 1995-01-27 | 157 | 0 |
| K941982 | CAPNOCHECK | Bci, Inc. | 1994-10-17 | 175 | 1 |
| K781918 | IRRIGATOR, BODY CAVITY | Bci, Inc. | 1979-02-15 | 94 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda