FDA product code · Microbiology
JWYManual Antimicrobial Susceptibility Test Systems
Product code JWY covers Manual Antimicrobial Susceptibility Test Systems, a Class II device regulated under 21 CFR 866.1640. FDA has cleared 441 devices in this code, 7 of them in the last 12 months. Median review time across the 441 most recent decisions is 69 days. openFDA lists 78 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 866.1640
- Review panel
- Microbiology
- Clearances
- 441
What is happening in JWY right now?
JWY (Manual Antimicrobial Susceptibility Test Systems): nothing changed in the six FDA sources we watch.
Checked predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Nothing changed, so there is nothing here — which is the point. We only write when something did.
How many devices has FDA cleared in JWY?
FDA has cleared 441 devices under product code JWY since the 510(k) programme began in 1976, 7 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260447 | ETEST Gepotidacin (GEP) (0.016-256 µg/mL) | bioMérieux SA | |
| K260696 | MTS Gepotidacin 0.016-256 µg/mL | Liofilchem s.r.l. | |
| K252114 | MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL | Liofilchem s.r.l. | |
| K252062 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL | Thermo Fisher Scientific | |
| K250575 | The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL | Thermo Fisher Scientific | |
| K252014 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mL | Thermo Fisher Scientific | |
| K251580 | MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD) | Liofilchem s.r.l. | |
| K250990 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mL | Thermo Fisher Scientific | |
| K242843 | The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL. | Thermo Fisher Scientific | |
| K250856 | ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL) | Biomérieux |
How long does FDA review take for JWY?
The median FDA review time for JWY is 69 days, measured across the 441 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 JWY?
openFDA lists 78 recall records against product code JWY. A recall record covers one firm's corrective action and may span many device lots.
Z-1947-2025Open, ClassifiedRemel, Inc.
Product may have an off color affecting perfomance
Z-0817-2023Open, ClassifiedbioMerieux, Inc.
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Z-0818-2023Open, ClassifiedbioMerieux, Inc.
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Z-0819-2023Open, ClassifiedbioMerieux, Inc.
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Z-0820-2023Open, ClassifiedbioMerieux, Inc.
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Showing the 5 most recently initiated of 78. 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 JWY?
MAUDE holds 4 adverse-event reports naming product code JWY.
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 JWY unusual?
JWY 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 | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history |
3 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 JWY?
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 JWY?
Across the 441 most recent decisions, these applicants filed most often in JWY.
| Applicant | Recent clearances |
|---|---|
| Ab Biodisk | 61 |
| Thermo Fisher Scientific | 47 |
| Trek Diagnostic Systems, Inc. | 44 |
| Pasco Laboratories, Inc. | 39 |
| Liofilchem s.r.l. | 35 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
One company in JWY files under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| Trek Diagnostic Systems | 51 | 3 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch JWY
Get an email the morning anything changes in JWY — 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.