510(k) · Cleared
ClearedVoriconazole 1UG BBL Sensi-Disc
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton, Dickinson & CO · JTN Susceptibility Test Discs, Antimicrobial
Cleared on Oct 2, 2008 as substantially equivalent to K874425 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1987) after a 52-day review. Its family tree reaches back 1 generation to 1987.
- Decided
- Oct 2, 2008
- Review
- 52 days
- Class
- Class II
- Product code
- JTN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K874425 (1987). No later device cites it as a predicate yet.
- Root · 1 generation backK874425 Ciprofloxacin 5 MCG Sensi-DiscBd Becton Dickinson Vacutainer Systems Preanalytic · 1987 · Recalled
- This deviceK082272 Voriconazole 1UG BBL Sensi-DiscBecton, Dickinson & CO · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K874425 | Ciprofloxacin 5 MCG Sensi-Disc | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1987 | 1 |
| 0 (this device) | K082272 | Voriconazole 1UG BBL Sensi-Disc | Becton, Dickinson & CO | 2008 | — |
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 JTN? 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 JTN device
- #1 K230651 BD BBL™ Sensi-Disc™ Lefamulin 20µg (LMU-20)score 5.5 · 1 generation · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K874425 | Ciprofloxacin 5 MCG Sensi-DiscSummary page 5…profloxacin (5 jig), was added to the BBLTM Sensi- DiscTM Antimicrobial Susceptibility Test Disks product line when FDA clearance was granted per premarket notification #K874425. Disks containing Ciprofloxacin are being used as one example of this product line and are the predicate device for this submissi… | 1987 |
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 a recall.
How does its category compare?
All JTN devicesJTN Susceptibility Test Discs, Antimicrobial: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · JTN
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JTN
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JTN
31in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JTN
7in 2025
MAUDE reports naming product code JTN, 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 | 1 | — | 1 | 2 |
| 2008 | 4 | 44 | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 3 | 15 | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 3 | 0 |
| 2013 | 0 | — | 5 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 3 | 56 | 1 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 3 | 33 | 0 | 0 |
| 2018 | 3 | 27 | 0 | 0 |
| 2019 | 3 | 23 | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 5 |
| 2022 | 2 | — | 0 | 5 |
| 2023 | 4 | 67 | 0 | 4 |
| 2024 | 2 | — | 31 | 5 |
| 2025 | 7 | 87 | 0 | 7 |
| 2026 | 4 | 56 | 1 | — |
What is it indicated for?
Use of Voriconazole 1 µg, BBL Sensi-Disc for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of pathogens to Voriconazole. The concentration of 1 µg has been shown to be active in vitro against most strains of Candida species listed below, as described in the FDA approved drug insert for this agent.
Active In Vitro and in Clinical Infections Against:
Candida albicans
Candida glabrata
Candida krusei
Candida parapsilosis
Candida tropicalis
Active In Vitro Against:
Candida lusitaniae
Candida guilliermondii
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082272 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082272: Voriconazole 1UG BBL Sensi-Disc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082272
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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