FDA product code JTN: Susceptibility Test Discs, Antimicrobial
JTN is the FDA product code for susceptibility test discs, antimicrobial. It is a Class II device, regulated under 21 CFR 866.1620 and reviewed by the Microbiology panel. FDA has cleared 331 510(k) submissions under JTN, 19 in the last five years, from 29 different applicants. The average 510(k) review took 65 days (median 54); 112 days on average over the last three years. 1 PMA application cites this product code. FDA has posted 47 recalls for JTN devices, 33 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Susceptibility Test Discs, Antimicrobial |
| Device class | Class II |
| Regulation | 21 CFR 866.1620 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for JTN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 3 | 42 |
| 2018 | 3 | 35 |
| 2019 | 3 | 29 |
| 2020 | 2 | 194 |
| 2021 | 2 | 220 |
| 2022 | 2 | 426 |
| 2023 | 4 | 65 |
| 2024 | 2 | 184 |
| 2025 | 7 | 98 |
| 2026 | 4 | 55 |
Compare with all 510(k) review times · Search every JTN clearance
Top JTN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hardy Diagnostics | 84 | 2026-08-20 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 43 | 2000-04-25 |
| Difco Laboratories, Inc. | 41 | 1997-04-14 |
| Oxoid , Ltd. | 31 | 2007-03-14 |
| Investigacion Farmaceutica S.A. DE C.V. | 19 | 1989-11-30 |
24 more applicants have JTN clearances. See the full list in Caduvo.
Most recent JTN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K262113 | Hardy Diagnostics | HardyDisk AST Tebipenem 10µg (TBP10) | 2026-08-20 | 58 |
| K261781 | Thermo Fisher Scientific (Oxoid Ltd.) | Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60 | 2026-07-24 | 56 |
| K261853 | Liofilchem, Inc. | Gepotidacin GEP 10 µg | 2026-07-23 | 50 |
| K260842 | Hardy Diagnostics | HardyDisk AST Gepotidacin 10µg (GEP10) | 2026-05-11 | 56 |
| K251337 | Thermo Fisher Scientific (Oxoid Ltd.) | Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10 | 2025-12-05 | 219 |
Recalls for JTN devices
47 product recalls in 15 recall events; 33 initiated in the last five years and 33 still open. Most recent: 2026-06-08.
| Year | Recalls |
|---|---|
| 2021 | 1 |
| 2024 | 32 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code JTN?
JTN is the FDA product code for susceptibility test discs, antimicrobial. It is a Class II device, regulated under 21 CFR 866.1620 and reviewed by the Microbiology panel.
What device class is JTN?
Class II, regulation 21 CFR 866.1620. Typical premarket route: 510(k).
How long does a 510(k) take for product code JTN?
Across 331 cleared submissions the average was 65 days from receipt to decision (median 54).
Which companies have the most JTN clearances?
Hardy Diagnostics (84); Bd Becton Dickinson Vacutainer Systems Preanalytic (43); Difco Laboratories, Inc. (41); Oxoid , Ltd. (31); Investigacion Farmaceutica S.A. DE C.V. (19).
Have JTN devices been recalled?
Yes: 47 product recalls across 15 recall events; the most recent began 2026-06-08.
Next steps
- Run an FDA pathway report with predicate devices for product code JTN
- Run a recall and safety report across every JTN manufacturer
- Watch product code JTN for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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