FDA product code LFB: Button, Nasal Septal
LFB is the FDA product code for button, nasal septal. It is a Unclassified device, reviewed by the Ear, Nose and Throat panel. FDA has cleared 12 510(k) submissions under LFB, from 12 different applicants. The average 510(k) review took 53 days (median 36). FDA has posted 2 recalls for LFB devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Button, Nasal Septal |
| Device class | Unclassified |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Unknown |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every LFB clearance
Top LFB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Helix Medical, LLC | 1 | 2013-09-17 |
| Silmed, Inc. | 1 | 2001-11-28 |
| Micromedics, Inc. | 1 | 1998-11-24 |
| Boston Medical Products, Inc. | 1 | 1997-07-03 |
| Hood Laboratories | 1 | 1992-05-15 |
7 more applicants have LFB clearances. See the full list in Caduvo.
Most recent LFB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K131745 | Helix Medical, LLC | BLOM-SINGER SEPTAL PERFORATION PROSTHESIS | 2013-09-17 | 96 |
| K013696 | Silmed, Inc. | SILMED NASAL SEPTAL BUTTON | 2001-11-28 | 21 |
| K982667 | Micromedics, Inc. | MICROMEDICS NASAL SEPTAL BUTTON | 1998-11-24 | 116 |
| K972060 | Boston Medical Products, Inc. | NASAL SEPTAL BUTTON | 1997-07-03 | 31 |
| K920994 | Hood Laboratories | HOOD NASAL SEPTAL BUTTON | 1992-05-15 | 74 |
Recalls for LFB devices
2 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-01-13.
| Year | Recalls |
|---|---|
| 2023 | 1 |
Frequently asked questions
What is FDA product code LFB?
LFB is the FDA product code for button, nasal septal. It is a Unclassified device, reviewed by the Ear, Nose and Throat panel.
What device class is LFB?
Unclassified. Typical premarket route: 510(k).
How long does a 510(k) take for product code LFB?
Across 12 cleared submissions the average was 53 days from receipt to decision (median 36).
Which companies have the most LFB clearances?
Helix Medical, LLC (1); Silmed, Inc. (1); Micromedics, Inc. (1); Boston Medical Products, Inc. (1); Hood Laboratories (1).
Have LFB devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2023-01-13.
Next steps
- Run an FDA pathway report with predicate devices for product code LFB
- Run a recall and safety report across every LFB manufacturer
- Watch product code LFB 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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