Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Becton Dickinson Microbiology Systems — Predicate Candidate Screening
33 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
67 daysmedian FDA review time
277 days90th percentile
33clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K993577 | CEFOTAXIME/CLAVULANIC, 30/10UG, BBL SENSI-DISC AND CEFTAZIDI | Becton Dickinson Microbiology Systems | 1999-12-01 | 41 | 0 |
| K984631 | BDPROBETEC ET CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEA | Becton Dickinson Microbiology Systems | 1999-11-04 | 309 | 2 |
| K981517 | CEFDINIR, 5 UG, SENSI-DISC | Becton Dickinson Microbiology Systems | 1998-06-09 | 42 | 0 |
| K980683 | TROVAFLOXACIN 10G, SENSI-DISC | Becton Dickinson Microbiology Systems | 1998-05-01 | 67 | 0 |
| K974578 | GREPAFLOXACIN, 5 MG, SENSI-DISC | Becton Dickinson Microbiology Systems | 1998-02-23 | 77 | 0 |
| 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 |
| K972758 | BACTEC MYCO/F-SPUTA CULTURE VIALS | Becton Dickinson Microbiology Systems | 1997-08-08 | 53 | 0 |
| K972098 | FOSFOMYCIN, 200 MG, SENSI-DISC | Becton Dickinson Microbiology Systems | 1997-07-28 | 54 | 0 |
| K970385 | SPARFLOZACIN, 5 MCG, SENSI-DISC | Becton Dickinson Microbiology Systems | 1997-03-10 | 35 | 0 |
| K970212 | LEVOFLOXACIN, 5MCG, SENSI-DISC | Becton Dickinson Microbiology Systems | 1997-03-06 | 44 | 1 |
| K965159 | CETIBUTEN, 30MCG, SENSI-DISC | Becton Dickinson Microbiology Systems | 1997-02-04 | 43 | 0 |
| K961730 | RAPID GRAM-POSITIVE ID SYSTEM | Becton Dickinson Microbiology Systems | 1997-02-04 | 277 | 0 |
| K963845 | MEROPENEM, 10 MCG, SENSI-DISC | Becton Dickinson Microbiology Systems | 1996-10-25 | 30 | 1 |
| K963036 | MUELLER HINTON II BROTH (CATION-ADJUSTED) WITH LYSED HORSE B | Becton Dickinson Microbiology Systems | 1996-10-07 | 63 | 0 |
| K962423 | BBLCRYSTAL NEISSERIA/HAEMOPHILUS (N/H) SYSTEM | Becton Dickinson Microbiology Systems | 1996-08-02 | 39 | 0 |
| K960420 | MUELLER HINTON AGAR WITH 5% SHEEP BLOOD | Becton Dickinson Microbiology Systems | 1996-04-04 | 66 | 0 |
| K951539 | ENTEROCOCCUS SCREENING MEDIUM | Becton Dickinson Microbiology Systems | 1995-06-13 | 71 | 4 |
| K950123 | SCEPTOR SYSTEM PANELS | Becton Dickinson Microbiology Systems | 1995-03-23 | 70 | 0 |
| K944528 | BBLCRYSTAL ANAEROBE ID SYSTEM | Becton Dickinson Microbiology Systems | 1995-03-07 | 173 | 0 |
| K945569 | GCII AGAR WITH ISOVITALX(R) ENRICHMENT | Becton Dickinson Microbiology Systems | 1995-02-02 | 114 | 0 |
| K941997 | BBL CRYSTAL MRSA ID SYSTEM | Becton Dickinson Microbiology Systems | 1995-01-27 | 277 | 0 |
| K943407 | GENTAMICIN 120 UG, STREPTOMYCIN 30 UG SENSI-DISC SUSPECTIBIL | Becton Dickinson Microbiology Systems | 1994-10-27 | 105 | 0 |
| K940359 | PIPERACILLIN/TOZOBACTAM, 100/10 MCG SENSI-DISC | Becton Dickinson Microbiology Systems | 1994-03-01 | 25 | 1 |
| K932882 | GC II AGAR WITH ISOVITALEX | Becton Dickinson Microbiology Systems | 1993-09-24 | 102 | 0 |
| K932879 | G C II AGAR WITH SENSIVITALEX | Becton Dickinson Microbiology Systems | 1993-09-21 | 99 | 0 |
| K926294 | BBL CRYSTAL MRSA ID SYSTEM | Becton Dickinson Microbiology Systems | 1993-05-18 | 155 | 0 |
| K926017 | CRYSTAL RAPID STOOL/ENTERIC ID SYSTEM | Becton Dickinson Microbiology Systems | 1993-03-11 | 101 | 0 |
| K926018 | CRYSTAL ENTERIC/NONFERMENTER ID SYSTEM | Becton Dickinson Microbiology Systems | 1993-03-11 | 101 | 2 |
| K926255 | BBL NITRATE A, B REAGENT DROPPERS | Becton Dickinson Microbiology Systems | 1993-01-26 | 39 | 0 |
| K926256 | BBL NINHYDRIN REAGENT DROPPERS | Becton Dickinson Microbiology Systems | 1993-01-26 | 39 | 0 |
| K926254 | BBL PYR REAGENT DROPPERS | Becton Dickinson Microbiology Systems | 1993-01-26 | 39 | 0 |
| K923952 | ENOXACIN 10 MCG. SENSI SISC | Becton Dickinson Microbiology Systems | 1992-09-18 | 43 | 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