FDA product code KCM: Dropper, Ent
KCM is the FDA product code for dropper, ent. It is a Class I device, regulated under 21 CFR 874.5220 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 1 510(k) submission under KCM. The average 510(k) review took 156 days (median 156). FDA has posted 2 recalls for KCM devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Dropper, Ent |
| 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 KCM clearance
Top KCM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| E.W. Link, Inc. | 1 | 1984-08-02 |
Most recent KCM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K840907 | E.W. Link, Inc. | POST-AID | 1984-08-02 | 156 |
Recalls for KCM devices
2 product recalls in 1 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2023-03-30.
| Year | Recalls |
|---|---|
| 2023 | 2 |
Frequently asked questions
What is FDA product code KCM?
KCM is the FDA product code for dropper, ent. 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 KCM?
Class I, regulation 21 CFR 874.5220. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KCM?
Across 1 cleared submissions the average was 156 days from receipt to decision (median 156).
Which companies have the most KCM clearances?
E.W. Link, Inc. (1).
Have KCM devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2023-03-30.
Next steps
- Run an FDA pathway report with predicate devices for product code KCM
- Run a recall and safety report across every KCM manufacturer
- Watch product code KCM 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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