FDA product code KAC: Tube, Laryngectomy
KAC is the FDA product code for tube, laryngectomy. It is a Class I device, regulated under 21 CFR 874.4420 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 4 510(k) submissions under KAC, from 4 different applicants. The average 510(k) review took 80 days (median 60). FDA has posted 1 recall for KAC devices.
Classification
| Field | Value |
|---|---|
| Device name | Tube, Laryngectomy |
| 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 KAC clearance
Top KAC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medical Innovations International, Inc. | 1 | 1990-06-14 |
| Portex, Inc. | 1 | 1988-03-24 |
| Shiley, Inc. | 1 | 1982-08-12 |
| Universal Prosthetics, Inc. | 1 | 1981-06-16 |
Most recent KAC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K901377 | Medical Innovations International, Inc. | BARTON-MAYO TRACHEOSTOMA BUTTON | 1990-06-14 | 84 |
| K873992 | Portex, Inc. | LARYNGECTOMY TUBE | 1988-03-24 | 175 |
| K821993 | Shiley, Inc. | SHILEY LARYNGECTOMY TUBE | 1982-08-12 | 36 |
| K811428 | Universal Prosthetics, Inc. | NORTHWESTERN VOICE RESTORATION KIT | 1981-06-16 | 25 |
Recalls for KAC devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2006-12-15.
Frequently asked questions
What is FDA product code KAC?
KAC is the FDA product code for tube, laryngectomy. 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 KAC?
Class I, regulation 21 CFR 874.4420. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KAC?
Across 4 cleared submissions the average was 80 days from receipt to decision (median 60).
Which companies have the most KAC clearances?
Medical Innovations International, Inc. (1); Portex, Inc. (1); Shiley, Inc. (1); Universal Prosthetics, Inc. (1).
Have KAC devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2006-12-15.
Next steps
- Run an FDA pathway report with predicate devices for product code KAC
- Run a recall and safety report across every KAC manufacturer
- Watch product code KAC 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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