FDA product code JSM: Culture Media, Non-Propagating Transport
JSM is the FDA product code for culture media, non-propagating transport. It is a Class I device, regulated under 21 CFR 866.2390 and reviewed by the Microbiology panel. FDA has cleared 111 510(k) submissions under JSM, 20 in the last five years, from 58 different applicants. The average 510(k) review took 136 days (median 73); 378 days on average over the last three years. FDA has posted 18 recalls for JSM devices, 7 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Culture Media, Non-Propagating Transport |
| Device class | Class I |
| Regulation | 21 CFR 866.2390 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for JSM
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 89 |
| 2018 | 1 | 74 |
| 2021 | 1 | 257 |
| 2022 | 5 | 332 |
| 2023 | 3 | 318 |
| 2024 | 9 | 462 |
| 2025 | 3 | 295 |
Compare with all 510(k) review times · Search every JSM clearance
Top JSM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Copan Diagnostics, Inc. | 8 | 2004-12-07 |
| Ncs Diagnostics, Inc. | 7 | 1994-11-30 |
| Medical Packaging Corp. | 6 | 1997-10-08 |
| Copan Italia Spa | 5 | 2024-10-11 |
| Remel Co. | 5 | 1997-01-22 |
53 more applicants have JSM clearances. See the full list in Caduvo.
Most recent JSM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K242976 | Medical Wire & Equipment Company (Bath), Ltd. | Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport Device | 2025-11-26 | 426 |
| K250205 | Jinan Babio Biotechnology Co., Ltd. | Babio® Virus Transport Kit (Non-inactivating) | 2025-09-22 | 241 |
| K242576 | Hangzhou AllTest Biotech Co., Ltd. | AllTest Viral Transport Medium | 2025-04-04 | 218 |
| K232565 | Copan Italia Spa | UriSponge | 2024-10-11 | 414 |
| K220908 | Ensol Biosciences, Inc. | Ensol EnTM Specimen Collection and Transport System | 2024-08-29 | 884 |
Recalls for JSM devices
18 product recalls in 11 recall events; 7 initiated in the last five years and 7 still open. Most recent: 2024-06-20.
| Year | Recalls |
|---|---|
| 2020 | 4 |
| 2021 | 3 |
| 2022 | 6 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code JSM?
JSM is the FDA product code for culture media, non-propagating transport. It is a Class I device, regulated under 21 CFR 866.2390 and reviewed by the Microbiology panel.
What device class is JSM?
Class I, regulation 21 CFR 866.2390. Typical premarket route: 510(k).
How long does a 510(k) take for product code JSM?
Across 111 cleared submissions the average was 136 days from receipt to decision (median 73).
Which companies have the most JSM clearances?
Copan Diagnostics, Inc. (8); Ncs Diagnostics, Inc. (7); Medical Packaging Corp. (6); Copan Italia Spa (5); Remel Co. (5).
Have JSM devices been recalled?
Yes: 18 product recalls across 11 recall events; the most recent began 2024-06-20.
Next steps
- Run an FDA pathway report with predicate devices for product code JSM
- Run a recall and safety report across every JSM manufacturer
- Watch product code JSM 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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