FDA product code KAD: Elevator, Ent
KAD is the FDA product code for elevator, ent. It is a Class I device, regulated under 21 CFR 874.4420 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 5 510(k) submissions under KAD, from 3 different applicants. The average 510(k) review took 38 days (median 21). FDA has posted 1 recall for KAD devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Elevator, Ent |
| Device class | Class I |
| Regulation | 21 CFR 874.4420 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) exempt |
Top KAD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kelleher Corp. | 2 | 1982-08-16 |
| Edward Weck, Inc. | 2 | 1978-01-17 |
| Treace Medical, Inc. | 1 | 1984-07-18 |
Most recent KAD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K841356 | Treace Medical, Inc. | ELEVATOR | 1984-07-18 | 107 |
| K822190 | Kelleher Corp. | ENT ELEVATORS | 1982-08-16 | 24 |
| K822270 | Kelleher Corp. | VARIOUS TYPES OF ENT ELEVATORS | 1982-08-16 | 18 |
| K772399 | Edward Weck, Inc. | DINGMAN ZYGOMA ELEVATOR | 1978-01-17 | 21 |
| K772391 | Edward Weck, Inc. | BOIES NASAL FRACTURE ELEVATOR | 1978-01-17 | 21 |
Recalls for KAD devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-12-03.
| Year | Recalls |
|---|---|
| 2024 | 1 |
Frequently asked questions
What is FDA product code KAD?
KAD is the FDA product code for elevator, ent. It is a Class I device, regulated under 21 CFR 874.4420 and reviewed by the Ear, Nose and Throat panel.
What device class is KAD?
Class I, regulation 21 CFR 874.4420. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KAD?
Across 5 cleared submissions the average was 38 days from receipt to decision (median 21).
Which companies have the most KAD clearances?
Kelleher Corp. (2); Edward Weck, Inc. (2); Treace Medical, Inc. (1).
Have KAD devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2024-12-03.
Next steps
- Run an FDA pathway report with predicate devices for product code KAD
- Run a recall and safety report across every KAD manufacturer
- Watch product code KAD 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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