FDA product code · Microbiology
JSICulture Media, Selective And Differential
Product code JSI covers Culture Media, Selective And Differential, a Class I device regulated under 21 CFR 866.2360. FDA has cleared 285 devices in this code. Median review time across the 285 most recent decisions is 23 days. openFDA lists 24 recall records against this code.
Updated · ingest status · JSON
- Class
- Class I
- Regulation
- 21 CFR 866.2360
- Review panel
- Microbiology
- Clearances
- 285
What is happening in JSI right now?
JSI (Culture Media, Selective And Differential): 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 JSI?
FDA has cleared 285 devices under product code JSI since the 510(k) programme began in 1976.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K070691 | BBL CHROMAGAR 0157 | Becton, Dickinson & CO | |
| K974428 | DIPSTREAK | Novamed , Ltd. | |
| K891593 | LISTERIA SELECTIVE ENRICHMENT MEDIUM | Oxoid U.S.A., Inc. | |
| K890199 | DENTOCULT SM-STRIP MUTANS | Orion Corp. | |
| K882182 | SALMONELLA-SHIGELLA (SS) AGAR - PRODUCT #P3326 | Lakewood Biochemical Co., Inc. | |
| K881577 | MODIFIED SELECTIVE STREPTOCOCCUS AGAR | Acumedia Manufacturers, Inc. | |
| K881576 | SELENITE BROTH | Acumedia Manufacturers, Inc. | |
| K881575 | SELECTIVE STREPTOCOCCUS AGAR | Acumedia Manufacturers, Inc. | |
| K881572 | XL AGAR BASE | Acumedia Manufacturers, Inc. | |
| K881556 | TRICHOMONAS BROTH | Acumedia Manufacturers, Inc. |
How long does FDA review take for JSI?
The median FDA review time for JSI is 23 days, measured across the 285 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 JSI?
openFDA lists 24 recall records against product code JSI. A recall record covers one firm's corrective action and may span many device lots.
Z-2224-2025Open, ClassifiedRemel, Inc.
The products may contain surface and subsurface contamination of Listeria monocytogenes.
Z-2225-2025Open, ClassifiedRemel, Inc.
The products may contain surface and subsurface contamination of Listeria monocytogenes.
Z-2226-2025Open, ClassifiedRemel, Inc.
The products may contain surface and subsurface contamination of Listeria monocytogenes.
Z-1829-2025Open, ClassifiedMckesson Medical-Surgical Inc. Corporate Office
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Z-1200-2025Open, ClassifiedRemel, Inc.
Product may contain surface and subsurface contamination of Listeria monocytogenes which is typically visible immediately upon removal from the packaging, appearing on the blood side of the biplate.
Showing the 5 most recently initiated of 24. 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 JSI?
MAUDE holds 97 adverse-event reports naming product code JSI, 38 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 JSI unusual?
JSI 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 |
|---|---|---|---|
| 3 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 7 | Insufficient history | No expected range — too little history | |
| 7 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 2 | 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 | |
| 1 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 7 | Insufficient history | No expected range — too little history | |
| 2 | 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 | |
| 4 | Insufficient history | No expected range — too little history | |
| 30 | 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 |
26 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 JSI?
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 JSI?
Across the 285 most recent decisions, these applicants filed most often in JSI.
| Applicant | Recent clearances |
|---|---|
| Acumedia Manufacturers, Inc. | 40 |
| Otisville Biotech, Inc. | 20 |
| Hardy Media | 17 |
| Isle Media and Sterile Products, Inc. | 15 |
| Lakewood Biochemical Co., Inc. | 14 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
Source: openFDA device/510k · retrieved
Watch JSI
Get an email the morning anything changes in JSI — 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.