Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MDB — Predicate Candidate Screening
68 FDA 510(k) clearances under this product code; the 50 most recent screened below.
89 daysmedian FDA review time
270 days90th percentile
68clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260213 | BD BACTEC FXI Culture System | BD Diagnostic Systems | 2026-05-28 | 125 | 0 |
| K222591 | BD BACTEC™ Plus Aerobic/F Culture Vials | Becton, Dickinson and Company | 2023-03-24 | 210 | 0 |
| K222559 | BD BACTEC™ Myco/F Lytic Culture Vials | Becton, Dickinson and Company | 2023-03-24 | 212 | 0 |
| K190405 | BACT/ALERT MP Reagent System | bioMerieux, Inc. | 2019-05-15 | 85 | 0 |
| K183166 | BacT/ALERT FA Plus; BacT/ALERT PF Plus | bioMerieux, Inc. | 2019-02-11 | 88 | 0 |
| K173873 | BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Br | Becton, Dickinson and Company | 2018-03-16 | 86 | 0 |
| K161816 | BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIR | bioMerieux, Inc. | 2017-03-28 | 270 | 0 |
| K161810 | BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein | Becton Dickinson | 2017-02-09 | 223 | 0 |
| K161306 | BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein | Becton Dickinson | 2016-08-08 | 90 | 0 |
| K151866 | BD BACTEC Peds Plus/F Culture Vials (plastic) | Becton, Dickinson and Company | 2016-02-25 | 231 | 0 |
| K141810 | BD BACTEC PLUS ANAEROBIC/F (PLASTIC) | Becton, Dickinson and Company | 2014-12-10 | 156 | 0 |
| K123903 | BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic) | Becton, Dickinson & CO | 2013-05-13 | 145 | 0 |
| K121455 | BACT/ALERT FN PLUS CULTURE BOTTLE | bioMerieux, Inc. | 2013-01-25 | 254 | 0 |
| K121446 | BACT/ALERT PF PLUS CULTURE BOTTLE | bioMerieux, Inc. | 2013-01-25 | 255 | 0 |
| K121461 | BACT/ALERT FA PLUS CULTURE BOTTLE | bioMerieux, Inc. | 2013-01-22 | 250 | 0 |
| K120994 | BD BACTEC Plus PRIME Aerobic/F Culture Vials | Becton, Dickinson and Company | 2012-08-07 | 127 | 0 |
| K113558 | BD BACTEC Plus Aerobic/F Culture Vials (plastic) | Becton, Dickinson and Company | 2012-03-16 | 106 | 1 |
| K083572 | BD BACTEC Plus Aerobic/F Culture Vials | Becton, Dickinson & CO | 2008-12-24 | 21 | 0 |
| K032306 | VERSATREK | Trek Diagnostic Systems, Inc. | 2003-08-22 | 28 | 2 |
| K031737 | BACT/ALERT MP CULTURE BOTTLES (PLASTIC) | bioMerieux, Inc. | 2003-07-14 | 40 | 0 |
| K021123 | BACT/ALERT SN CULTURE BOTTLE | bioMerieux, Inc. | 2002-04-26 | 18 | 1 |
| K020815 | BACT/ALERT FN CULTURE BOTTLE | bioMerieux, Inc. | 2002-04-18 | 36 | 0 |
| K020923 | BACT/ALERT PF CULTURE BOTTLE | bioMerieux, Inc. | 2002-04-18 | 28 | 0 |
| K020931 | BACT/ALERT SA CULTURE BOTTLE | bioMerieux, Inc. | 2002-04-18 | 27 | 1 |
| K020813 | BACT/ALERT FA CULTURE BOTTLE | bioMerieux, Inc. | 2002-04-17 | 35 | 2 |
| K000378 | BACT/ALERT MB CULTURE BOTTLE | Organon Teknika Corp. | 2000-03-02 | 24 | 0 |
| K994343 | BACT/ALERT SV | Organon Teknika Corp. | 2000-02-10 | 49 | 0 |
| K993423 | BACT/ALERT SA | Organon Teknika Corp. | 1999-12-15 | 64 | 0 |
| K993421 | BACT/ALERT SN | Organon Teknika Corp. | 1999-12-14 | 63 | 0 |
| K993576 | BACT/ALERT MP PROCESS BOTTLE | Organon Teknika Corp. | 1999-12-14 | 54 | 0 |
| K992432 | BACT/ALERT FN | Organon Teknika Corp. | 1999-09-24 | 65 | 1 |
| K992401 | BACT/ALERT PF | Organon Teknika Corp. | 1999-09-03 | 46 | 0 |
| K992400 | BACTALERT FA | Organon Teknika Corp. | 1999-09-03 | 46 | 0 |
| K983772 | MB/BACT BLOOD CULTURE BOTTLE | Organon Teknika Corp. | 1999-01-13 | 79 | 0 |
| K982263 | MB/BACT BLOOD CULTURE BOTTLE | Organon Teknika Corp. | 1998-08-18 | 50 | 0 |
| K981736 | BACT/ALERT 3D MICROBIAL DETECTION SYSTEM | Organon Teknika Corp. | 1998-07-24 | 67 | 2 |
| K974883 | BACTEC MGIT 960 SYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1998-05-01 | 122 | 2 |
| K970333 | BACTEC MYCO/F LYTIC CULTURE VIALS | Becton Dickinson Microbiology Systems | 1998-01-28 | 365 | 0 |
| K970512 | BACTEC MYCO/F LYTIC CULTURE VIALS | Becton Dickinson Microbiology Systems | 1998-01-08 | 331 | 0 |
| K973325 | BACT/ALERT FAN CULTURE BOTTLES | Organon Teknika Corp. | 1997-12-02 | 89 | 0 |
| K973305 | BACT/ALERT CULTURE BOTTLES | Organon Teknika Corp. | 1997-11-17 | 75 | 0 |
| K972758 | BACTEC MYCO/F-SPUTA CULTURE VIALS | Becton Dickinson Microbiology Systems | 1997-08-08 | 53 | 0 |
| K972756 | MODIFICATION OF EST CULTURE SYSTEM II - MYCO | Accumed Intl., Inc. | 1997-08-01 | 63 | 0 |
| K954932 | BBL MGIT PRODUCTS | Becton Dickinson Diagnostic Instrument Systems | 1996-08-21 | 299 | 0 |
| K962210 | BACTEC 9050 SYSTEM | Becton Dickinson Diagnostic Instrument Systems | 1996-08-08 | 59 | 0 |
| K954468 | MB/BACT MYCROBACTERIA DETECTION SYSTEM | Organon Teknika Corp. | 1996-07-22 | 300 | 2 |
| K946268 | BACTEC(R) 9000TB SYSTEM | Becton Dickinson Diagnostic Instrument Systems | 1996-05-21 | 515 | 0 |
| K954927 | BACTEC PEDS PLUS/F CULTURE VIALS | Becton Dickinson Diagnostic Instrument Systems | 1996-02-16 | 113 | 0 |
| K954930 | BACTEC CULTURE VIALS, LYTIC, ANAEROBIC | Becton Dickinson Diagnostic Instrument Systems | 1996-02-16 | 113 | 0 |
| K954921 | BACTEC STANDARD/10 AEROBIC/F CULTURE VIALS | Becton Dickinson Diagnostic Instrument Systems | 1996-02-16 | 113 | 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