FDA product code MDB: System, Blood Culturing
MDB is the FDA product code for system, blood culturing. It is a Class I device, regulated under 21 CFR 866.2560 and reviewed by the Microbiology panel. FDA has cleared 68 510(k) submissions under MDB, 3 in the last five years, from 14 different applicants. The average 510(k) review took 122 days (median 88); 125 days on average over the last three years. FDA has posted 76 recalls for MDB devices, 7 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | System, Blood Culturing |
| Device class | Class I |
| Regulation | 21 CFR 866.2560 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for MDB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 246 |
| 2018 | 1 | 86 |
| 2019 | 2 | 86 |
| 2023 | 2 | 211 |
| 2026 | 1 | 125 |
Compare with all 510(k) review times · Search every MDB clearance
Top MDB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Organon Teknika Corp. | 19 | 2000-03-02 |
| bioMerieux, Inc. | 12 | 2019-05-15 |
| Becton Dickinson Diagnostic Instrument Systems | 8 | 1996-08-21 |
| Becton, Dickinson and Company | 7 | 2023-03-24 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 7 | 1998-05-01 |
9 more applicants have MDB clearances. See the full list in Caduvo.
Most recent MDB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260213 | BD Diagnostic Systems | BD BACTEC FXI Culture System | 2026-05-28 | 125 |
| K222559 | Becton, Dickinson and Company | BD BACTEC Myco/F Lytic Culture Vials | 2023-03-24 | 212 |
| K222591 | Becton, Dickinson and Company | BD BACTEC Plus Aerobic/F Culture Vials | 2023-03-24 | 210 |
| K190405 | bioMerieux, Inc. | BACT/ALERT MP Reagent System | 2019-05-15 | 85 |
| K183166 | bioMerieux, Inc. | BacT/ALERT FA Plus; BacT/ALERT PF Plus | 2019-02-11 | 88 |
Recalls for MDB devices
76 product recalls in 28 recall events; 7 initiated in the last five years and 7 still open. Most recent: 2025-09-23.
| Year | Recalls |
|---|---|
| 2018 | 3 |
| 2023 | 1 |
| 2024 | 4 |
| 2025 | 2 |
Frequently asked questions
What is FDA product code MDB?
MDB is the FDA product code for system, blood culturing. It is a Class I device, regulated under 21 CFR 866.2560 and reviewed by the Microbiology panel.
What device class is MDB?
Class I, regulation 21 CFR 866.2560. Typical premarket route: 510(k).
How long does a 510(k) take for product code MDB?
Across 68 cleared submissions the average was 122 days from receipt to decision (median 88).
Which companies have the most MDB clearances?
Organon Teknika Corp. (19); bioMerieux, Inc. (12); Becton Dickinson Diagnostic Instrument Systems (8); Becton, Dickinson and Company (7); Bd Becton Dickinson Vacutainer Systems Preanalytic (7).
Have MDB devices been recalled?
Yes: 76 product recalls across 28 recall events; the most recent began 2025-09-23.
Next steps
- Run an FDA pathway report with predicate devices for product code MDB
- Run a recall and safety report across every MDB manufacturer
- Watch product code MDB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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