FDA product code KAL: Retractor, Ent
KAL is the FDA product code for retractor, 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 KAL, from 4 different applicants. The average 510(k) review took 55 days (median 21). FDA has posted 1 recall for KAL devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Retractor, 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 KAL clearance
Top KAL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Edward Weck, Inc. | 2 | 1978-01-17 |
| Treace Medical, Inc. | 1 | 1987-03-04 |
| Microtek Medical, Inc. | 1 | 1984-01-03 |
| V. Mueller O.V. Baxter Healthcare Corp. | 1 | 1977-03-10 |
Most recent KAL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K870758 | Treace Medical, Inc. | SMALL MASTOID RETRACTOR | 1987-03-04 | 6 |
| K833604 | Microtek Medical, Inc. | ADJUSTABLE FORK RETRACTOR | 1984-01-03 | 83 |
| K772392 | Edward Weck, Inc. | ALLPORT MASTOID RETRACTORS | 1978-01-17 | 21 |
| K772381 | Edward Weck, Inc. | RING HANDLE & RETRACTORS | 1978-01-17 | 21 |
| K760851 | V. Mueller O.V. Baxter Healthcare Corp. | CONVERSE ALTAR RETRACTOR | 1977-03-10 | 146 |
Recalls for KAL devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-05-25.
| Year | Recalls |
|---|---|
| 2023 | 1 |
Frequently asked questions
What is FDA product code KAL?
KAL is the FDA product code for retractor, 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 KAL?
Class I, regulation 21 CFR 874.4420. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KAL?
Across 5 cleared submissions the average was 55 days from receipt to decision (median 21).
Which companies have the most KAL clearances?
Edward Weck, Inc. (2); Treace Medical, Inc. (1); Microtek Medical, Inc. (1); V. Mueller O.V. Baxter Healthcare Corp. (1).
Have KAL devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2023-05-25.
Next steps
- Run an FDA pathway report with predicate devices for product code KAL
- Run a recall and safety report across every KAL manufacturer
- Watch product code KAL 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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