FDA product code JTB: Device, Media Dispensing/Stacking
JTB is the FDA product code for device, media dispensing/stacking. It is a Class I device, regulated under 21 CFR 866.2440 and reviewed by the Microbiology panel. FDA has cleared 2 510(k) submissions under JTB, from 2 different applicants. The average 510(k) review took 32 days (median 32).
Classification
| Field | Value |
|---|---|
| Device name | Device, Media Dispensing/Stacking |
| Device class | Class I |
| Regulation | 21 CFR 866.2440 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every JTB clearance
Top JTB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Acacia, Inc. | 1 | 1980-10-31 |
| Diagnostic Products Corp. | 1 | 1979-05-03 |
Most recent JTB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K802561 | Acacia, Inc. | HI VOLUME PUMPING CHAMBER | 1980-10-31 | 15 |
| K790514 | Diagnostic Products Corp. | I NETILMICIN RIA KIT | 1979-05-03 | 49 |
Recalls for JTB devices
openFDA lists no recalls for product code JTB.
Frequently asked questions
What is FDA product code JTB?
JTB is the FDA product code for device, media dispensing/stacking. It is a Class I device, regulated under 21 CFR 866.2440 and reviewed by the Microbiology panel.
What device class is JTB?
Class I, regulation 21 CFR 866.2440. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JTB?
Across 2 cleared submissions the average was 32 days from receipt to decision (median 32).
Which companies have the most JTB clearances?
Acacia, Inc. (1); Diagnostic Products Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JTB
- Run a recall and safety report across every JTB manufacturer
- Watch product code JTB 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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