FDA product code KTH: Device, Anti-Stammering
KTH is the FDA product code for device, anti-stammering. It is a Class I device, regulated under 21 CFR 874.5840 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 4 510(k) submissions under KTH, from 4 different applicants. The average 510(k) review took 180 days (median 103).
Classification
| Field | Value |
|---|---|
| Device name | Device, Anti-Stammering |
| Device class | Class I |
| Regulation | 21 CFR 874.5840 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KTH clearance
Top KTH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Surface Mount Technology, Inc. | 1 | 1996-09-09 |
| Casa Futura Technologies | 1 | 1995-10-19 |
| Vocaltech C/O Hogan & Hartson | 1 | 1987-10-06 |
| Foundation For Fluency, Inc. | 1 | 1980-03-12 |
Most recent KTH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K962961 | Surface Mount Technology, Inc. | SUSTAINED PHONATION | 1996-09-09 | 41 |
| K942651 | Casa Futura Technologies | BIOFEEDBACK SYSTEM FOR SPEECH DISORDERS | 1995-10-19 | 503 |
| K871590 | Vocaltech C/O Hogan & Hartson | VOCALTECH VOCAL FEEDBACK DEVICE | 1987-10-06 | 165 |
| K800445 | Foundation For Fluency, Inc. | EDINBURGH MASKER | 1980-03-12 | 13 |
Recalls for KTH devices
openFDA lists no recalls for product code KTH.
Frequently asked questions
What is FDA product code KTH?
KTH is the FDA product code for device, anti-stammering. It is a Class I device, regulated under 21 CFR 874.5840 and reviewed by the Ear, Nose and Throat panel.
What device class is KTH?
Class I, regulation 21 CFR 874.5840. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KTH?
Across 4 cleared submissions the average was 180 days from receipt to decision (median 103).
Which companies have the most KTH clearances?
Surface Mount Technology, Inc. (1); Casa Futura Technologies (1); Vocaltech C/O Hogan & Hartson (1); Foundation For Fluency, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KTH
- Run a recall and safety report across every KTH manufacturer
- Watch product code KTH 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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