FDA product code KTD: Orthosis, Abdominal
KTD is the FDA product code for orthosis, abdominal. It is a Class I device, regulated under 21 CFR 890.3490 and reviewed by the Physical Medicine panel. FDA has cleared 3 510(k) submissions under KTD, from 2 different applicants. The average 510(k) review took 22 days (median 22).
Classification
| Field | Value |
|---|---|
| Device name | Orthosis, Abdominal |
| Device class | Class I |
| Regulation | 21 CFR 890.3490 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every KTD clearance
Top KTD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Warm & Form, Orthopedic Materials | 2 | 1982-12-30 |
| Biomet, Inc. | 1 | 1978-03-02 |
Most recent KTD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K823663 | Warm & Form, Orthopedic Materials | ABDOMINAL BINDER | 1982-12-30 | 24 |
| K823164 | Warm & Form, Orthopedic Materials | ABDOMINAL BINDER | 1982-11-16 | 22 |
| K780229 | Biomet, Inc. | ABDOMINAL BELT | 1978-03-02 | 21 |
Recalls for KTD devices
openFDA lists no recalls for product code KTD.
Frequently asked questions
What is FDA product code KTD?
KTD is the FDA product code for orthosis, abdominal. It is a Class I device, regulated under 21 CFR 890.3490 and reviewed by the Physical Medicine panel.
What device class is KTD?
Class I, regulation 21 CFR 890.3490. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KTD?
Across 3 cleared submissions the average was 22 days from receipt to decision (median 22).
Which companies have the most KTD clearances?
Warm & Form, Orthopedic Materials (2); Biomet, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KTD
- Run a recall and safety report across every KTD manufacturer
- Watch product code KTD 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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