Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Becton Dickinson Vacutainer Systems — Predicate Candidate Screening
15 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
58 daysmedian FDA review time
99 days90th percentile
15clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K002456 | MICROTAINER BRAND SODIUM FLUORIDE/EDTA TUBE WITH MICROGARD C | Becton Dickinson Vacutainer Systems | 2000-11-02 | 84 | 2 |
| K991702 | MICROTAINER BRAND CHEMISTRY TUBES WITH MICROGARD CLOSURE, MO | Becton Dickinson Vacutainer Systems | 1999-07-28 | 70 | 1 |
| K991088 | VACUTAINER BRAND MULTIPLE SAMPLE LUER ADAPTER, BLOOD COLLECT | Becton Dickinson Vacutainer Systems | 1999-05-28 | 57 | 2 |
| K991120 | VACUTAINER BRAND CTAD TUBE (MULTIPLE) | Becton Dickinson Vacutainer Systems | 1999-05-19 | 47 | 0 |
| K982541 | VACUTAINER BRAND ECLIPSE BLOOD COLLECTION NEEDLE, MODELS# 36 | Becton Dickinson Vacutainer Systems | 1998-10-28 | 99 | 1 |
| K982922 | VACUTAINER BRAND BLOOD COLLECTION SYRINGE | Becton Dickinson Vacutainer Systems | 1998-09-22 | 34 | 0 |
| K981013 | VACUTAINER PLUS TUBE WITH EDTA ANTICOAGULANT ANDD VACUTAINER | Becton Dickinson Vacutainer Systems | 1998-06-17 | 91 | 8 |
| K972075 | VACUTAINER BRAND PPT PLASMA PREPARATION TUBE | Becton Dickinson Vacutainer Systems | 1998-02-24 | 266 | 0 |
| K980098 | VACUTAINER BRAND PRONTO NEEDLES HOLDER | Becton Dickinson Vacutainer Systems | 1998-02-05 | 24 | 0 |
| K971449 | VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE) | Becton Dickinson Vacutainer Systems | 1997-06-17 | 57 | 1 |
| K960250 | VACUTAINER BRAND PLUS SERUM & SST TUBES | Becton Dickinson Vacutainer Systems | 1996-03-29 | 73 | 3 |
| K954592 | VACUTAINER BRAND PST PLASMA SEPARATION TUBE | Becton Dickinson Vacutainer Systems | 1995-11-28 | 57 | 1 |
| K953994 | SEDITAINER* ERYTHROCYTE SEDIMENTATION RATE (ESR) SYSTEM | Becton Dickinson Vacutainer Systems | 1995-09-26 | 33 | 0 |
| K953463 | VACUTAINER PLUS TUBES | Becton Dickinson Vacutainer Systems | 1995-09-20 | 58 | 0 |
| K951886 | LOK-ON NEEDLE DISPOSAL SYSTEM | Becton Dickinson Vacutainer Systems | 1995-06-30 | 67 | 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