FDA product code KLX: Electroglottograph
KLX is the FDA product code for electroglottograph. It is a Class II device, regulated under 21 CFR 874.1325 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 4 510(k) submissions under KLX, from 4 different applicants. The average 510(k) review took 56 days (median 60).
Classification
| Field | Value |
|---|---|
| Device name | Electroglottograph |
| Device class | Class II |
| Regulation | 21 CFR 874.1325 |
| 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 KLX clearance
Top KLX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kay Elemetrics Corp. | 1 | 1999-03-11 |
| Glottal Ent., Inc. | 1 | 1990-06-28 |
| Teltec Electronic Equipment AB | 1 | 1984-07-18 |
| Ms. Kate Teaney | 1 | 1982-05-10 |
Most recent KLX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K990240 | Kay Elemetrics Corp. | ELECTROGLOTTOGRAPH | 1999-03-11 | 45 |
| K901609 | Glottal Ent., Inc. | ELECTROGLOTTOGRAPH | 1990-06-28 | 83 |
| K841832 | Teltec Electronic Equipment AB | GLOTTAL FREQUENCY ANALYSER | 1984-07-18 | 76 |
| K821079 | Ms. Kate Teaney | ELECTROGLOTTOGRAPH NAKED EGG BOXED EGG | 1982-05-10 | 21 |
Recalls for KLX devices
openFDA lists no recalls for product code KLX.
Frequently asked questions
What is FDA product code KLX?
KLX is the FDA product code for electroglottograph. It is a Class II device, regulated under 21 CFR 874.1325 and reviewed by the Ear, Nose and Throat panel.
What device class is KLX?
Class II, regulation 21 CFR 874.1325. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KLX?
Across 4 cleared submissions the average was 56 days from receipt to decision (median 60).
Which companies have the most KLX clearances?
Kay Elemetrics Corp. (1); Glottal Ent., Inc. (1); Teltec Electronic Equipment AB (1); Ms. Kate Teaney (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KLX
- Run a recall and safety report across every KLX manufacturer
- Watch product code KLX 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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