FDA product code KAI: Mirror, Ent
KAI is the FDA product code for mirror, 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 9 510(k) submissions under KAI, from 6 different applicants. The average 510(k) review took 37 days (median 28). FDA has posted 1 recall for KAI devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Mirror, 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 |
Compare with all 510(k) review times · Search every KAI clearance
Top KAI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Treace Medical, Inc. | 2 | 1983-01-21 |
| Kelleher Corp. | 2 | 1982-08-30 |
| Welch Allyn, Inc. | 2 | 1977-01-18 |
| Microtek Medical, Inc. | 1 | 1984-01-03 |
| Jedmed Instrument Co. | 1 | 1982-03-01 |
1 more applicants have KAI clearances. See the full list in Caduvo.
Most recent KAI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K833601 | Microtek Medical, Inc. | ANTRUM & ATTIC MIRROR | 1984-01-03 | 83 |
| K823915 | Treace Medical, Inc. | MIRROR TIP | 1983-01-21 | 24 |
| K822374 | Treace Medical, Inc. | BUCKINGHAM ATTIC & ANTRUM MIRROR | 1982-09-09 | 34 |
| K822261 | Kelleher Corp. | LARYNGEAL MIRRORS | 1982-08-30 | 32 |
| K822191 | Kelleher Corp. | HEAD MIRROR WITH HEADBAND | 1982-08-20 | 28 |
Recalls for KAI devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-02-23.
| Year | Recalls |
|---|---|
| 2024 | 1 |
Frequently asked questions
What is FDA product code KAI?
KAI is the FDA product code for mirror, 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 KAI?
Class I, regulation 21 CFR 874.4420. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KAI?
Across 9 cleared submissions the average was 37 days from receipt to decision (median 28).
Which companies have the most KAI clearances?
Treace Medical, Inc. (2); Kelleher Corp. (2); Welch Allyn, Inc. (2); Microtek Medical, Inc. (1); Jedmed Instrument Co. (1).
Have KAI devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2024-02-23.
Next steps
- Run an FDA pathway report with predicate devices for product code KAI
- Run a recall and safety report across every KAI manufacturer
- Watch product code KAI 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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