FDA product code KCN: Ear Wick
KCN is the FDA product code for ear wick. It is a Class I device, regulated under 21 CFR 874.5220 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 4 510(k) submissions under KCN, from 4 different applicants. The average 510(k) review took 127 days (median 48). FDA has posted 6 recalls for KCN devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Ear Wick |
| Device class | Class I |
| Regulation | 21 CFR 874.5220 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every KCN clearance
Top KCN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Polyganics B.V., | 1 | 2006-10-18 |
| Invotec International, Inc. | 1 | 1997-11-06 |
| Ultracell Medical Technologies, Inc. | 1 | 1993-02-01 |
| Xomed, Inc. | 1 | 1979-07-17 |
Most recent KCN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K062540 | Polyganics B.V., | NASOPORE EAR, MODELS ND04, ND05 | 2006-10-18 | 49 |
| K973578 | Invotec International, Inc. | INVOTEC EAR TAMPON (WICK) W/STRING | 1997-11-06 | 48 |
| K920357 | Ultracell Medical Technologies, Inc. | ULTRACELL EAR WICK | 1993-02-01 | 371 |
| K791059 | Xomed, Inc. | POPE OTO-WICK, STERILE & NON-STERILE | 1979-07-17 | 39 |
Recalls for KCN devices
6 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-05-25.
| Year | Recalls |
|---|---|
| 2022 | 1 |
Frequently asked questions
What is FDA product code KCN?
KCN is the FDA product code for ear wick. It is a Class I device, regulated under 21 CFR 874.5220 and reviewed by the Ear, Nose and Throat panel.
What device class is KCN?
Class I, regulation 21 CFR 874.5220. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KCN?
Across 4 cleared submissions the average was 127 days from receipt to decision (median 48).
Which companies have the most KCN clearances?
Polyganics B.V., (1); Invotec International, Inc. (1); Ultracell Medical Technologies, Inc. (1); Xomed, Inc. (1).
Have KCN devices been recalled?
Yes: 6 product recalls across 2 recall events; the most recent began 2022-05-25.
Next steps
- Run an FDA pathway report with predicate devices for product code KCN
- Run a recall and safety report across every KCN manufacturer
- Watch product code KCN 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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