Bd Becton Dickinson Vacutainer Systems Preanalytic: FDA clearances and approvals
Bd Becton Dickinson Vacutainer Systems Preanalytic has 632 FDA 510(k) clearances (first 1976, latest 2001), plus 2 PMA decisions, across 238 product codes in 15 review panels. Median 510(k) review time: 47 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JTN | Susceptibility Test Discs, Antimicrobial | 43 | 43 |
| JWY | Manual Antimicrobial Susceptibility Test Systems | 32 | 32 |
| FMF | Syringe, Piston | 23 | 23 |
| FMI | Needle, Hypodermic, Single Lumen | 20 | 20 |
| JSJ | Culture Media, Selective And Non-Differential | 16 | 16 |
| GKZ | Counter, Differential Cell | 15 | 15 |
| FRN | Pump, Infusion | 14 | 14 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 13 | 13 |
| LYZ | Vinyl Patient Examination Glove | 13 | 13 |
| GKL | Counter, Cell, Automated (Particle Counter) | 11 | 11 |
Plus 228 more product codes.
Review panels
- Microbiology (221)
- Clinical Chemistry (127)
- General Hospital (112)
- Hematology (52)
- Anesthesiology (21)
- Cardiovascular (19)
- General and Plastic Surgery (17)
- Clinical Toxicology (16)
- Gastroenterology and Urology (12)
- Immunology (11)
- Pathology (6)
- Physical Medicine (5)
- Obstetrics and Gynecology (3)
- Ear, Nose and Throat (1)
- Radiology (1)
Most recent Bd Becton Dickinson Vacutainer Systems Preanalytic 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K003062 | BACTEC MGIT 960 SIR KITS | MJA | 2001-06-06 | 247 |
| K003553 | 0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE | FOZ | 2001-03-21 | 124 |
| K003461 | BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE | FMI | 2001-02-01 | 86 |
| K002938 | B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16 | FMI | 2000-11-29 | 69 |
| K001364 | BD DIRECTIGEN FLU A+B | PSZ | 2000-06-28 | 58 |
| K000762 | MOXIFLOXACIN, 5 UG, BBL SENSI-DISC | JTN | 2000-04-25 | 48 |
| K000829 | GATIFLOXACIN, 5 UG, BBL SENSI-DISC | JTN | 2000-04-13 | 30 |
| K993186 | SYNERCID, 15 UG, BBL SENSI-DISC | JTN | 1999-11-03 | 42 |
| K992734 | BECTON DICKINSON SYRINGE | MEG | 1999-10-01 | 49 |
| K992849 | QBC STAR CENTRIFUGAL HEMATOLOGY SYSTEM | GKZ | 1999-09-23 | 30 |
622 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P800030 | PMA | BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC | 1981-02-18 |
| P780011 | PMA | MINI BALLOON | 1980-05-15 |
Recalls
openFDA lists no recalls under a recalling firm named Bd Becton Dickinson Vacutainer Systems Preanalytic.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Bd Becton Dickinson Vacutainer Systems Preanalytic's product codes (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- G0008 — Administration of influenza virus vaccine (via PSZ)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
- G0379 — Direct admission of patient for hospital observation care (via CAF)
Frequently asked questions
How many FDA 510(k) clearances does Bd Becton Dickinson Vacutainer Systems Preanalytic have?
Bd Becton Dickinson Vacutainer Systems Preanalytic has 632 FDA 510(k) clearances (first 1976, latest 2001), plus 2 PMA decisions, across 238 product codes in 15 review panels.
How long does FDA take to clear Bd Becton Dickinson Vacutainer Systems Preanalytic's 510(k)s?
The median time from FDA receipt to decision across Bd Becton Dickinson Vacutainer Systems Preanalytic's cleared 510(k)s is 47 days.
What devices does Bd Becton Dickinson Vacutainer Systems Preanalytic make?
Its most frequent FDA product codes are JTN (Susceptibility Test Discs, Antimicrobial, 43); JWY (Manual Antimicrobial Susceptibility Test Systems, 32); FMF (Syringe, Piston, 23).
Has Bd Becton Dickinson Vacutainer Systems Preanalytic had device recalls?
openFDA lists no recalls under a recalling firm name matching Bd Becton Dickinson Vacutainer Systems Preanalytic. Related entities may recall under other names.
Next steps
- See all 632 Bd Becton Dickinson Vacutainer Systems Preanalytic clearances with predicates and recalls
- Run predicate analysis for product code JTN, Bd Becton Dickinson Vacutainer Systems Preanalytic's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.