510(k) · Cleared
ClearedMB/Bact Blood Culture Bottle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Organon Teknika Corp. · MDB System, Blood Culturing
Cleared on Aug 18, 1998 as substantially equivalent to K863191 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1986) after a 50-day review. Its family tree reaches back 1 generation to 1986.
- Decided
- Aug 18, 1998
- Review
- 50 days
- Class
- Class I
- Product code
- MDB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K863191 (1986). No later device cites it as a predicate yet.
- Root · 1 generation backK863191 Bactec 13A Medium (7H13)Bd Becton Dickinson Vacutainer Systems Preanalytic · 1986
- This deviceK982263 MB/Bact Blood Culture BottleOrganon Teknika Corp. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K863191 | Bactec 13A Medium (7H13) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1986 | — |
| 0 (this device) | K982263 | MB/Bact Blood Culture Bottle | Organon Teknika Corp. | 1998 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MDB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MDB device
- #1 K260213 BD BACTEC FXI Culture Systemscore 11.4 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K863191 | Bactec 13A Medium (7H13)Summary page 2…ntification of the legally marketed device to which the submitter claims substantial equivalence; Device Equivalent to: BACTEC 13A Blood Bottle - Becton Dickinson & Co.(K863191) (a)(4) A description of the device. Device Description: MB/BacT Blood Culture Bottles are specifically designed forthe cultiva… | 1986 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K863191.
How does its category compare?
All MDB devicesMDB System, Blood Culturing: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MDB
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · MDB
252in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MDB
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MDB
1,977in 2025
MAUDE reports naming product code MDB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 2 | 1 |
| 2008 | 1 | — | 0 | 3 |
| 2009 | 0 | — | 4 | 1 |
| 2010 | 0 | — | 2 | 1 |
| 2011 | 0 | — | 2 | 6 |
| 2012 | 2 | — | 33 | 4 |
| 2013 | 4 | 252 | 3 | 5 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 2 | 12 |
| 2016 | 2 | — | 0 | 291 |
| 2017 | 2 | — | 0 | 121 |
| 2018 | 1 | — | 3 | 76 |
| 2019 | 2 | — | 0 | 147 |
| 2020 | 0 | — | 0 | 37 |
| 2021 | 0 | — | 0 | 1,184 |
| 2022 | 0 | — | 0 | 643 |
| 2023 | 2 | — | 1 | 1,232 |
| 2024 | 0 | — | 4 | 401 |
| 2025 | 0 | — | 2 | 1,977 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
MB/BacT Blood Culture Bottles in combination with the MB/BacT Enrichment Fluid are specifically designed for the cultivation of Mpycobacterium sp. commonly isolated from blood when used in conjunction with the MB/BacT Mycobacterial Detection System.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982263 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982263: MB/Bact Blood Culture Bottle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982263
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026