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

JTA — Predicate Candidate Screening

11 FDA 510(k) clearances under this product code; the 50 most recent screened below.

42 daysmedian FDA review time

76 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days
K954923	BACTEC FUNGAL MEDIUM	Becton Dickinson Diagnostic Instrument Systems	1996-11-21	392
K910835	BACTEC NR-860	Bd Becton Dickinson Vacutainer Systems Preanalytic	1991-03-11	12
K865021	BACTEC(R) NR-660 HIGH PERFORMANCE SYSTEM	Bd Becton Dickinson Vacutainer Systems Preanalytic	1987-02-06	45
K853011	BACTEC NR-730 BACTERIAL DETECTION SYSTEM	Bd Becton Dickinson Vacutainer Systems Preanalytic	1985-07-30	14
K842874	RADIOMETRIC BLOOD CULTURE VIALS, AEROBE	American Micro Scan	1984-09-12	51
K842279	BECTEC NR-660 BACTERIAL DETECT SYS	Bd Becton Dickinson Vacutainer Systems Preanalytic	1984-07-20	42
K833917	BAC-T-SCREEN	Marion Laboratories, Inc.	1984-01-13	60
K834264	REVERSE-FLOW SYSTEM	Applied Polytechnology, Inc.	1984-01-13	36
K810042	BACTEC BACTERIAL DETECTION SYSTEM: #5	Bd Becton Dickinson Vacutainer Systems Preanalytic	1981-01-28	21
K792575	BACTEC BACTERIAL DETECTION SYSTEM	Bd Becton Dickinson Vacutainer Systems Preanalytic	1979-12-27	14
K790297	DETECTION SYSTEM, MS-2 ELECTROCHEMICAL	Abbott Laboratories	1979-04-26	76

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