FDA product code JTW: System, Transport, Aerobic
JTW is the FDA product code for system, transport, aerobic. It is a Class I device, regulated under 21 CFR 866.2900 and reviewed by the Microbiology panel. FDA has cleared 43 510(k) submissions under JTW, from 21 different applicants. The average 510(k) review took 34 days (median 29). FDA has posted 8 recalls for JTW devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | System, Transport, Aerobic |
| Device class | Class I |
| Regulation | 21 CFR 866.2900 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every JTW clearance
Top JTW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Precision Dynamics Corp. | 9 | 1988-07-08 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 5 | 1984-09-27 |
| Difco Laboratories, Inc. | 3 | 1996-04-26 |
| Preventive Diagnostics Corp. | 3 | 1984-03-23 |
| Copan Diagnostics, Inc. | 2 | 2006-06-23 |
16 more applicants have JTW clearances. See the full list in Caduvo.
Most recent JTW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K121039 | Copan Flock Technologies | COPAN MSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM | 2012-05-25 | 50 |
| K061301 | Copan Diagnostics, Inc. | COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT SYSTEM | 2006-06-23 | 44 |
| K022874 | Gen-Probe, Inc. | GEN-PROBE APTIMA COMBO 2 ASSAY | 2002-09-17 | 53 |
| K013819 | Sierra Diagnostic, LLC | URINE COLLECTION, PRESERVATION AND TRANSPORT SYSTEM | 2002-02-28 | 104 |
| K993161 | Copan Diagnostics, Inc. | COPAN EASY-SWAB COLLECTION AND TRANSPORT SYSTEM | 1999-11-09 | 48 |
Recalls for JTW devices
8 product recalls in 5 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2025-05-02.
| Year | Recalls |
|---|---|
| 2018 | 4 |
| 2022 | 2 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code JTW?
JTW is the FDA product code for system, transport, aerobic. It is a Class I device, regulated under 21 CFR 866.2900 and reviewed by the Microbiology panel.
What device class is JTW?
Class I, regulation 21 CFR 866.2900. Typical premarket route: 510(k).
How long does a 510(k) take for product code JTW?
Across 43 cleared submissions the average was 34 days from receipt to decision (median 29).
Which companies have the most JTW clearances?
Precision Dynamics Corp. (9); Bd Becton Dickinson Vacutainer Systems Preanalytic (5); Difco Laboratories, Inc. (3); Preventive Diagnostics Corp. (3); Copan Diagnostics, Inc. (2).
Have JTW devices been recalled?
Yes: 8 product recalls across 5 recall events; the most recent began 2025-05-02.
Next steps
- Run an FDA pathway report with predicate devices for product code JTW
- Run a recall and safety report across every JTW manufacturer
- Watch product code JTW 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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