FDA product code LWF: Dilator, Nasal
LWF is the FDA product code for dilator, nasal. It is a Class I device, regulated under 21 CFR 874.3900 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 20 510(k) submissions under LWF, from 15 different applicants. The average 510(k) review took 155 days (median 87).
Classification
| Field | Value |
|---|---|
| Device name | Dilator, Nasal |
| Device class | Class I |
| Regulation | 21 CFR 874.3900 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) exempt |
510(k) clearances per year for LWF
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 88 |
Compare with all 510(k) review times · Search every LWF clearance
Top LWF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cns, Inc. | 4 | 1996-05-30 |
| Acutek Adhesive Specialties, Inc. | 2 | 1996-09-09 |
| Corbett Lair, Inc. | 2 | 1995-12-21 |
| Cpapnea Medical Supply | 1 | 2018-08-03 |
| Ventus Medical, Inc. | 1 | 2012-06-12 |
10 more applicants have LWF clearances. See the full list in Caduvo.
Most recent LWF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K181219 | Cpapnea Medical Supply | OptiPillows EPAP Mask | 2018-08-03 | 88 |
| K120665 | Ventus Medical, Inc. | INVENT SNORING DEVICE | 2012-06-12 | 99 |
| K040491 | Dale Miller, Inc. - the Chin-Up Company | CHIN-UP STRIP | 2004-09-10 | 197 |
| K982929 | Hnl Technologies | MAXAIR NASAL DILATOR SYSTEM | 1998-09-09 | 20 |
| K963326 | Cambridge Assoc. | BREATHE FIT | 1997-02-12 | 173 |
Recalls for LWF devices
openFDA lists no recalls for product code LWF.
Frequently asked questions
What is FDA product code LWF?
LWF is the FDA product code for dilator, nasal. It is a Class I device, regulated under 21 CFR 874.3900 and reviewed by the Ear, Nose and Throat panel.
What device class is LWF?
Class I, regulation 21 CFR 874.3900. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LWF?
Across 20 cleared submissions the average was 155 days from receipt to decision (median 87).
Which companies have the most LWF clearances?
Cns, Inc. (4); Acutek Adhesive Specialties, Inc. (2); Corbett Lair, Inc. (2); Cpapnea Medical Supply (1); Ventus Medical, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LWF
- Run a recall and safety report across every LWF manufacturer
- Watch product code LWF 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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