FDA product code KBN: Gag, Mouth
KBN is the FDA product code for gag, mouth. It is a Class I device, regulated under 21 CFR 874.4420 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 3 510(k) submissions under KBN, from 3 different applicants. The average 510(k) review took 61 days (median 64). FDA has posted 1 recall for KBN devices.
Classification
| Field | Value |
|---|---|
| Device name | Gag, Mouth |
| 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 KBN clearance
Top KBN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Imm Enterprises , Ltd. | 1 | 1984-03-06 |
| Kelleher Corp. | 1 | 1982-08-16 |
| Nestor Engineering Associates, Inc. | 1 | 1978-08-17 |
Most recent KBN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K834540 | Imm Enterprises , Ltd. | OP-CON SURGICAL INSTRUMENT #9 | 1984-03-06 | 96 |
| K822183 | Kelleher Corp. | MOUTH GAGS | 1982-08-16 | 24 |
| K780992 | Nestor Engineering Associates, Inc. | MILLARD MOUTH GAG | 1978-08-17 | 64 |
Recalls for KBN devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-02-16.
| Year | Recalls |
|---|---|
| 2018 | 1 |
Frequently asked questions
What is FDA product code KBN?
KBN is the FDA product code for gag, mouth. 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 KBN?
Class I, regulation 21 CFR 874.4420. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KBN?
Across 3 cleared submissions the average was 61 days from receipt to decision (median 64).
Which companies have the most KBN clearances?
Imm Enterprises , Ltd. (1); Kelleher Corp. (1); Nestor Engineering Associates, Inc. (1).
Have KBN devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2018-02-16.
Next steps
- Run an FDA pathway report with predicate devices for product code KBN
- Run a recall and safety report across every KBN manufacturer
- Watch product code KBN 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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