FDA product code KHH: Stimulator, Caloric-Air
KHH is the FDA product code for stimulator, caloric-air. It is a Class I device, regulated under 21 CFR 874.1800 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 7 510(k) submissions under KHH, from 5 different applicants. The average 510(k) review took 123 days (median 127).
Classification
| Field | Value |
|---|---|
| Device name | Stimulator, Caloric-Air |
| Device class | Class I |
| Regulation | 21 CFR 874.1800 |
| 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 KHH clearance
Top KHH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ics Medical Corp. | 3 | 1993-06-22 |
| Jedmed Instrument Co. | 1 | 1995-06-28 |
| Life-Tech Intl., Inc. | 1 | 1995-06-13 |
| Strong Medical, Inc. | 1 | 1994-08-09 |
| Kelleher Corp. | 1 | 1982-09-21 |
Most recent KHH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K950785 | Jedmed Instrument Co. | HORTMANN AIRMATIC AIR CALORIC STIMULATOR | 1995-06-28 | 127 |
| K946108 | Life-Tech Intl., Inc. | EAR-A-GATOR | 1995-06-13 | 181 |
| K941325 | Strong Medical, Inc. | WATER IRRIGATOR, W1 200 | 1994-08-09 | 144 |
| K931608 | Ics Medical Corp. | NCA-200 | 1993-06-22 | 82 |
| K925237 | Ics Medical Corp. | AUTOMATIC CALORIC IRRIGATION SYSTEM | 1993-05-05 | 201 |
Recalls for KHH devices
openFDA lists no recalls for product code KHH.
Frequently asked questions
What is FDA product code KHH?
KHH is the FDA product code for stimulator, caloric-air. It is a Class I device, regulated under 21 CFR 874.1800 and reviewed by the Ear, Nose and Throat panel.
What device class is KHH?
Class I, regulation 21 CFR 874.1800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KHH?
Across 7 cleared submissions the average was 123 days from receipt to decision (median 127).
Which companies have the most KHH clearances?
Ics Medical Corp. (3); Jedmed Instrument Co. (1); Life-Tech Intl., Inc. (1); Strong Medical, Inc. (1); Kelleher Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KHH
- Run a recall and safety report across every KHH manufacturer
- Watch product code KHH 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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