510(k) · Cleared
ClearedGrepafloxacin, 5 MG, Sensi-Disc
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton Dickinson Microbiology Systems · JTN Susceptibility Test Discs, Antimicrobial
Cleared on Feb 23, 1998 after a 77-day review. The FDA summary names its predicate without a number.
- Decided
- Feb 23, 1998
- Review
- 77 days
- Class
- Class II
- Product code
- JTN
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 |
|---|---|---|---|
| * | — | Ciprofloxacin, 5 mcg, Sensi-Disc Named without a submission number |
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.
How does its category compare?
All JTN devicesJTN Susceptibility Test Discs, Antimicrobial: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 BBL Grepafloxacin Sensi-Discs® for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to Grepafloxacin. Grepafloxacin has been shown to be active against most strains of microorganisms listed below, both in vitro and in clinical infections, as described in the GlaxoWellcome package insert for this antimicrobic. Aerobic Gram-Positive Microorganisms Streptococcus pneumoniae…
Read the full statement (176 words)
Use of BBL Grepafloxacin Sensi-Discs® for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to Grepafloxacin. Grepafloxacin has been shown to be active against most strains of microorganisms listed below, both in vitro and in clinical infections, as described in the GlaxoWellcome package insert for this antimicrobic.
Aerobic Gram-Positive Microorganisms
Streptococcus pneumoniae (penicillin-susceptible strains)
Aerobic Gram-Negative Microorganisms
Haemophilus influenzae
Neisseria gonorrhoeae
Moraxella catarrhalis
Other microorganisms:
Chlamydia trachomatis
Mycoplasma pneumoniae
Grepafloxacin exhibits in vitro minimum inhibitory concentrations (MICs) of 1ug/ml or less against most (>90%) strains of the following microorganisms; however, the safety and effectiveness of grepafloxacin in treating clinical infections due to these microorganisms have not been established in adequate and well-controlled clinical trials.
Aerobic Gram-Positive Microorganisms (In Vitro Only)
Staphylococcus aureus (methicillin-susceptible strains)
Staphylococcus epidermidis (methicillin-susceptible strains)
Streptococcus agalactiae
Streptococcus pneumoniae (penicillin-resistant strains)
Streptococcus pyogenes
Aerobic Gram-Negative Microorganisms (In Vitro Only)
Citrobacter freundii
Citrobacter (diversus) koseri
Enterobacter aerogenes
Enterobacter cloacae
Escherichia coli
Haemophilus parainfluenzae
Klebsiella oxytoca
Klebsiella pneumoniae
Morganella morganii
Proteus mirabilis
Proteus vulgaris
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/K974578 · printed Nov 5, 2026
Cite this page
510(k) Report. “K974578: Grepafloxacin, 5 MG, Sensi-Disc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K974578
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026