Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bci Intl., Inc. — Predicate Candidate Screening
20 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
87 daysmedian FDA review time
236 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K991410 | 3402 HANDHELD PULSE OXIMETER | Bci Intl., Inc. | 1999-06-09 | 48 | 0 |
| K991086 | CAPNOCHECK II, MODEL 8400 | Bci Intl., Inc. | 1999-06-09 | 70 | 1 |
| K984618 | BCI MINI-TORR PLUS, MODEL 6004 | Bci Intl., Inc. | 1999-03-25 | 86 | 1 |
| K983796 | 6004 NIBP MONITOR WITH TEMPERATURE | Bci Intl., Inc. | 1999-01-22 | 87 | 1 |
| K982279 | VITAL SIGNS MONITOR; ADVISOR MODEL # BCI 9200 | Bci Intl., Inc. | 1998-09-25 | 87 | 40 |
| K981939 | AUTOCORR PLUS; 3404 OXIMETER/ECG MONITOR | Bci Intl., Inc. | 1998-08-20 | 79 | 2 |
| K980714 | BCI 3401 HANDHELD PULSE OXIMETER | Bci Intl., Inc. | 1998-03-25 | 29 | 0 |
| K974697 | REUSABLE FINGER SENSOR 3444 | Bci Intl., Inc. | 1998-03-11 | 85 | 0 |
| K970801 | BCI MODEL 6004 NIBP MONITOR (6004) | Bci Intl., Inc. | 1997-11-12 | 253 | 1 |
| K970209 | CAPNOCHECK PLUS | Bci Intl., Inc. | 1997-04-18 | 87 | 1 |
| K963496 | OXI TEMP | Bci Intl., Inc. | 1996-11-26 | 84 | 0 |
| K962156 | 3304 PULSE OXIMETER | Bci Intl., Inc. | 1996-08-28 | 85 | 0 |
| K960058 | OXITEMP, 3301T SA | Bci Intl., Inc. | 1996-05-15 | 134 | 0 |
| K953415 | 6200 VITAL SIGNS MONITOR | Bci Intl., Inc. | 1995-10-19 | 91 | 0 |
| K953126 | OXILINK (SMALL, MEDIUM, LARGE) | Bci Intl., Inc. | 1995-09-21 | 78 | 0 |
| K945754 | NEWOX2 | Bci Intl., Inc. | 1995-07-17 | 236 | 0 |
| K946185 | 3301T OXITEMP | Bci Intl., Inc. | 1995-03-17 | 87 | 0 |
| K941971 | 9100 MUTIGAS MONITOR | Bci Intl., Inc. | 1994-11-21 | 213 | 0 |
| K943404 | 3301 PULSE OXIMETER | Bci Intl., Inc. | 1994-10-13 | 91 | 0 |
| K941289 | PULSE OXIMETER | Bci Intl., Inc. | 1994-06-22 | 97 | 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