510(k) · Cleared
ClearedBD BACTEC™ Myco/F Lytic Culture Vials
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton, Dickinson and Company · MDB System, Blood Culturing
Cleared on Mar 24, 2023 as substantially equivalent to K970333 (Becton Dickinson Microbiology Systems, 1998) and 1 other predicate after a 212-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Mar 24, 2023
- Review
- 212 days
- Class
- Class I
- Product code
- MDB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K970512 (1998). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK970512 Bactec Myco/F Lytic Culture VialsBecton Dickinson Microbiology Systems · 1998
- This deviceK222559 BD BACTEC™ Myco/F Lytic Culture VialsBecton, Dickinson and Company · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K970512 | Bactec Myco/F Lytic Culture Vials | Becton Dickinson Microbiology Systems | 1998 | — |
| 0 (this device) | K222559 | BD BACTEC™ Myco/F Lytic Culture Vials | Becton, Dickinson and Company | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
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
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K970333 | Bactec Myco/F Lytic Culture VialsSummary page 3…rescent series instrument. V Substantial Equivalence Information: A Predicate Device Name(s): BD BACTEC Myco/f Lytic Culture Vials B Predicate 510(k) Number(s): K970333, K970512 C Comparison with Predicates Device & Predicate Dev… | 1998 |
| * | K970512 | Bactec Myco/F Lytic Culture VialsSummary page 3…eries instrument. V Substantial Equivalence Information: A Predicate Device Name(s): BD BACTEC Myco/f Lytic Culture Vials B Predicate 510(k) Number(s): K970333, K970512 C Comparison with Predicates Device & Predicate Dev Pr… | 1998 |
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?
- None of the 2 ancestors has a recall.
How does its category compare?
All MDB devicesMDB System, Blood Culturing: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
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?
BD BACTEC Myco/F Lytic culture medium when used with the BD BACTEC fluorescent series instruments is a nonselective culture medium to be used as an adjunct to aerobic blood culture media for the qualitative culture and recovery of mycobacteria, yeast and fungi from blood. This medium may also be used for the culture of sterile body fluids when yeast or fungi are suspected.
The device aids in the diagnosis of disease caused by pathogenic microorganisms and is automated on the BD BACTEC fluorescent series instruments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222559 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222559: BD BACTEC™ Myco/F Lytic Culture Vials.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222559
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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