510(k) · Cleared
ClearedBactec Myco/F Lytic Culture Vials
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton Dickinson Microbiology Systems · MDB System, Blood Culturing
Cleared on Jan 28, 1998 after a 365-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Jan 28, 1998
- Review
- 365 days
- Class
- Class I
- Product code
- MDB
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK970333 Bactec Myco/F Lytic Culture VialsBecton Dickinson Microbiology Systems · 1998
- Descendant · cites it directly · 0 of its ownK222559 BD BACTEC™ Myco/F Lytic Culture VialsBecton, Dickinson and Company · 2023
Most influential descendants
Showing 1 of 1 · See all- K222559BD BACTEC™ Myco/F Lytic Culture VialsBecton, Dickinson and Company · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970333 | Bactec Myco/F Lytic Culture Vials | Becton Dickinson Microbiology Systems | 1998 | — |
| +1 | K222559 | BD BACTEC™ Myco/F Lytic Culture Vials | Becton, Dickinson and Company | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | — | BACTEC 13A Mycobacteria Culture Medium Named without a submission number | |
| * | — | BACTEC NR Fungal Culture Medium Named without a submission number | |
| * | — | ISOLATOR™ System Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222559 | BD BACTEC™ Myco/F Lytic Culture Vials | 2023 | 0 |
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?
- Of its descendants, K222559 (Becton, Dickinson and Company, 2023) has gone furthest, with 0 descendants of its own.
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?
The BACTEC® MYCO/F Lytic culture vials when used with the 9000 Blood Culture series of instrumentation are intended as an adjunct to routine blood culture for patients suspected of having mycobacteria, yeast and fungi septicemia. Extended incubation times (7 days for yeast, 30 days for fungi, and 42 days for mycobacteria) will permit recovery of mycobacteria and fungi when more rapidly growing organisms are not present. This medium may also be used for the culture of sterile body fluids when yeast or fungi are suspected.
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/K970333 · printed Nov 5, 2026
Cite this page
510(k) Report. “K970333: Bactec Myco/F Lytic Culture Vials.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K970333
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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