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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Becton Dickinson Diagnostic Instrument Systems — Predicate Candidate Screening

13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

113 daysmedian FDA review time
392 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K954923BACTEC FUNGAL MEDIUMBecton Dickinson Diagnostic Instrument Systems1996-11-213920
K954932BBL MGIT PRODUCTSBecton Dickinson Diagnostic Instrument Systems1996-08-212990
K962210BACTEC 9050 SYSTEMBecton Dickinson Diagnostic Instrument Systems1996-08-08590
K946268BACTEC(R) 9000TB SYSTEMBecton Dickinson Diagnostic Instrument Systems1996-05-215150
K960827QBC ACCUTUBE(423406)/QBC AUTOREAD(424571)Becton Dickinson Diagnostic Instrument Systems1996-05-17780
K954927BACTEC PEDS PLUS/F CULTURE VIALSBecton Dickinson Diagnostic Instrument Systems1996-02-161130
K954930BACTEC CULTURE VIALS, LYTIC, ANAEROBICBecton Dickinson Diagnostic Instrument Systems1996-02-161130
K954921BACTEC STANDARD/10 AEROBIC/F CULTURE VIALSBecton Dickinson Diagnostic Instrument Systems1996-02-161130
K954925BACTEC LYTIC/10 ANAEROBIC/F CULTURE VIALSBecton Dickinson Diagnostic Instrument Systems1996-02-161130
K954924BACTEC PEDS PLUS CLUTURE VIALSBecton Dickinson Diagnostic Instrument Systems1996-02-081050
K955504QBC ACCUREAD SYSTEMBecton Dickinson Diagnostic Instrument Systems1996-02-05660
K953340QBC ACCUTUBEBecton Dickinson Diagnostic Instrument Systems1995-10-05800
K945205QBC ACCUTUBEBecton Dickinson Diagnostic Instrument Systems1995-09-253350

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