FDA product code KBD: Scissors, Nasal
KBD is the FDA product code for scissors, nasal. 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 KBD, from 3 different applicants. The average 510(k) review took 25 days (median 17).
Classification
| Field | Value |
|---|---|
| Device name | Scissors, Nasal |
| 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 KBD clearance
Top KBD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Artiberia | 1 | 1985-06-11 |
| Kelleher Corp. | 1 | 1982-09-09 |
| Xomed, Inc. | 1 | 1979-06-27 |
Most recent KBD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K851763 | Artiberia | 13-320,13-330 TWO TYPES NAZAL SCISSORS-HEYMAN,BECK | 1985-06-11 | 47 |
| K822524 | Kelleher Corp. | EAR SPOON | 1982-09-09 | 17 |
| K791124 | Xomed, Inc. | SURGICAL SCISSORS | 1979-06-27 | 12 |
Recalls for KBD devices
openFDA lists no recalls for product code KBD.
Frequently asked questions
What is FDA product code KBD?
KBD is the FDA product code for scissors, nasal. 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 KBD?
Class I, regulation 21 CFR 874.4420. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KBD?
Across 3 cleared submissions the average was 25 days from receipt to decision (median 17).
Which companies have the most KBD clearances?
Artiberia (1); Kelleher Corp. (1); Xomed, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KBD
- Run a recall and safety report across every KBD manufacturer
- Watch product code KBD 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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