FDA product code · Microbiology
JTNSusceptibility Test Discs, Antimicrobial
Product code JTN covers Susceptibility Test Discs, Antimicrobial, a Class II device regulated under 21 CFR 866.1620. FDA has cleared 330 devices in this code, 6 of them in the last 12 months. Median review time across the 330 most recent decisions is 53 days. openFDA lists 47 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 866.1620
- Review panel
- Microbiology
- Clearances
- 330
What is happening in JTN right now?
JTN (Susceptibility Test Discs, Antimicrobial) has one finding. 1 recall opened in the last 12 months and not yet terminated (Z-2887-2026).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Serious | Z-2887-2026 |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in JTN?
FDA has cleared 330 devices under product code JTN since the 510(k) programme began in 1976, 6 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261781 | Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60 | Thermo Fisher Scientific (Oxoid Ltd.) | |
| K261853 | Gepotidacin GEP 10 µg | Liofilchem, Inc. | |
| K260842 | HardyDisk AST Gepotidacin 10µg (GEP10) | Hardy Diagnostics | |
| K251337 | Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10 | Thermo Fisher Scientific (Oxoid Ltd.) | |
| K253105 | HardyDisk AST Cefiderocol 30µg (FDC30) | Hardy Diagnostics | |
| K251879 | Sulopenem SPM 2 µg | Liofilchem | |
| K250956 | HardyDisk AST Gepotidacin 10µg (GEP10) | Hardy Diagnostics | |
| K250885 | Ceftobiprole BPR 5 µg Disc | Liofilchem, Inc. | |
| K250789 | Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50 | Thermo Fisher Scientific (Oxoid Ltd.) | |
| K250454 | HardyDisk Aztreonam/Avibactam 30/20µg (AZA50) | Hardy Diagnostics |
How long does FDA review take for JTN?
The median FDA review time for JTN is 53 days, measured across the 330 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in JTN?
openFDA lists 47 recall records against product code JTN. A recall record covers one firm's corrective action and may span many device lots.
Z-2887-2026Open, ClassifiedHardy Diagnostics
Due to incorrect cartridges include in affected products that there is the potential for false-susceptible or false-resistant susceptibility results and may lead to selection of an ineffective antimicrobial therapy, potentially resulting in delayed appropriate treatment, prolonged infection, or worsening clinical outcome.
Z-1075-2025Open, ClassifiedOxoid Limited
Mislabeling; Levofloxacin Antimicrobial susceptibility disc packaging may contain Norfloxacin Antimicrobial Susceptibility discs.
Z-0621-2025Open, ClassifiedBecton, Dickinson and Company
BD identified through potency testing as part of a stability test request to monitor Ampicillin AM-2 due to decrease in potency results of 65% at 18 months, may result in falsely resistant result for ampicillin susceptibility
Z-1011-2024Open, ClassifiedBecton, Dickinson and Company
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.
Z-1012-2024Open, ClassifiedBecton, Dickinson and Company
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.
Showing the 5 most recently initiated of 47. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for JTN?
MAUDE holds 14 adverse-event reports naming product code JTN, 4 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in JTN unusual?
JTN does not yet have twelve months of adverse-event history in our data, so there is no expected range to compare against. That is a gap in what we hold, not a statement about the device.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history |
9 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike.
What are the predicate devices in JTN?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in JTN?
Across the 330 most recent decisions, these applicants filed most often in JTN.
| Applicant | Recent clearances |
|---|---|
| Hardy Diagnostics | 83 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 43 |
| Difco Laboratories, Inc. | 41 |
| Oxoid , Ltd. | 31 |
| Investigacion Farmaceutica S.A. DE C.V. | 19 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
Source: openFDA device/510k · retrieved
Watch JTN
Get an email the morning anything changes in JTN — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.