FDA product code JSI: Culture Media, Selective And Differential
JSI is the FDA product code for culture media, selective and differential. It is a Class I device, regulated under 21 CFR 866.2360 and reviewed by the Microbiology panel. FDA has cleared 285 510(k) submissions under JSI, from 46 different applicants. The average 510(k) review took 34 days (median 23). FDA has posted 24 recalls for JSI devices, 8 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Culture Media, Selective And Differential |
| Device class | Class I |
| Regulation | 21 CFR 866.2360 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JSI clearance
Top JSI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Acumedia Manufacturers, Inc. | 40 | 1988-04-18 |
| Otisville Biotech, Inc. | 20 | 1986-07-03 |
| Hardy Media | 17 | 1988-03-31 |
| Isle Media and Sterile Products, Inc. | 15 | 1980-02-13 |
| Lakewood Biochemical Co., Inc. | 14 | 1988-06-06 |
41 more applicants have JSI clearances. See the full list in Caduvo.
Most recent JSI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K070691 | Becton, Dickinson & CO | BBL CHROMAGAR 0157 | 2007-11-20 | 252 |
| K974428 | Novamed , Ltd. | DIPSTREAK | 1998-07-30 | 248 |
| K891593 | Oxoid U.S.A., Inc. | LISTERIA SELECTIVE ENRICHMENT MEDIUM | 1989-06-09 | 81 |
| K890199 | Orion Corp. | DENTOCULT SM-STRIP MUTANS | 1989-03-02 | 43 |
| K882182 | Lakewood Biochemical Co., Inc. | SALMONELLA-SHIGELLA (SS) AGAR - PRODUCT #P3326 | 1988-06-06 | 13 |
Recalls for JSI devices
24 product recalls in 16 recall events; 8 initiated in the last five years and 8 still open. Most recent: 2025-07-11.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2020 | 1 |
| 2022 | 2 |
| 2025 | 6 |
Frequently asked questions
What is FDA product code JSI?
JSI is the FDA product code for culture media, selective and differential. It is a Class I device, regulated under 21 CFR 866.2360 and reviewed by the Microbiology panel.
What device class is JSI?
Class I, regulation 21 CFR 866.2360. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JSI?
Across 285 cleared submissions the average was 34 days from receipt to decision (median 23).
Which companies have the most JSI clearances?
Acumedia Manufacturers, Inc. (40); Otisville Biotech, Inc. (20); Hardy Media (17); Isle Media and Sterile Products, Inc. (15); Lakewood Biochemical Co., Inc. (14).
Have JSI devices been recalled?
Yes: 24 product recalls across 16 recall events; the most recent began 2025-07-11.
Next steps
- Run an FDA pathway report with predicate devices for product code JSI
- Run a recall and safety report across every JSI manufacturer
- Watch product code JSI 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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