510(k) · Cleared
ClearedBactec Lytic/10 Anaerobic/F Culture Vials
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton Dickinson Diagnostic Instrument Systems · MDB System, Blood Culturing
Cleared on Feb 16, 1996 after a 113-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.
- Decided
- Feb 16, 1996
- Review
- 113 days
- Class
- Class I
- Product code
- MDB
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK954925 Bactec Lytic/10 Anaerobic/F Culture VialsBecton Dickinson Diagnostic Instrument Systems · 1996
- Descendant · cites it directly · 0 of its ownK141810 BD Bactec Plus Anaerobic/F (Plastic)Becton, Dickinson and Company · 2014
- Descendant · cites it directly · 0 of its ownK123903 BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic)Becton, Dickinson & CO · 2013
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K954925 | Bactec Lytic/10 Anaerobic/F Culture Vials | Becton Dickinson Diagnostic Instrument Systems | 1996 | — |
| +1 | K141810 | BD Bactec Plus Anaerobic/F (Plastic) | Becton, Dickinson and Company | 2014 | — |
| +1 | K123903 | BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic) | Becton, Dickinson & CO | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K141810 (Becton, Dickinson and Company, 2014) 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 | — |
https://510kreport.com/device/K954925 · printed Nov 6, 2026
Cite this page
510(k) Report. “K954925: Bactec Lytic/10 Anaerobic/F 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/K954925
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026