LWF
20 FDA 510(k) clearances · Product code
88 daysmedian time to decision
549 days90th percentile
20clearances measured
FDA profile
- Official device name
- Dilator, Nasal
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.3900
- Medical specialty
- Ear, Nose, Throat
- Adverse events (MAUDE)
- 2014: 12 · 2015: 41 · 2016: 39 · 2017: 13 · 2018: 15 · 2019: 13
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| OptiPillows EPAP Mask (K181219) | Cpapnea Medical Supply | 2018-08-03 |
| INVENT SNORING DEVICE (K120665) | Ventus Medical, Inc. | 2012-06-12 |
| CHIN-UP STRIP (K040491) | Dale Miller, Inc. - the Chin-Up Company | 2004-09-10 |
| MAXAIR NASAL DILATOR SYSTEM (K982929) | Hnl Technologies | 1998-09-09 |
| BREATHE FIT (K963326) | Cambridge Assoc. | 1997-02-12 |
| AIR MAX EXTERNAL NASAL DILATOR STRIP (K962400) | American White Cross, Inc. | 1996-09-09 |
| ACUTEK'S CLEARPASAGE (K962698) | Acutek Adhesive Specialties, Inc. | 1996-09-09 |
| BREATHE RIGHT NASAL STRIP (K955711) | Cns, Inc. | 1996-05-30 |
| BREATHE RIGHT NASAL STRIP (K954914) | Cns, Inc. | 1996-02-27 |
| EASY BREATHING NASAL STRIPS (K955233) | Corbett Lair, Inc. | 1995-12-21 |
| E-Z BREATHERS (K953042) | E-Z Kare Good Health Systems, Inc. | 1995-12-08 |
| BURGET NASAL STENT (K942025) | Bivona Medical Technologies | 1995-10-27 |
| BREATHE RIGHT NASAL STRIP (K953772) | Cns, Inc. | 1995-10-20 |
| EASY BREATHING NASAL STRIPS (K954252) | Corbett Lair, Inc. | 1995-10-18 |
| ACUTEK'S CLEARPASSAGE (K951644) | Acutek Adhesive Specialties, Inc. | 1995-07-03 |
| BREATHE RIGHT (K921220) | Cns, Inc. | 1993-10-07 |
| NOZOVENT, NASAL DILATOR (K904290) | Wpm Intl AB Intl Trade & Managemet Consulting | 1991-08-20 |
| NOSE BRACE (K882131) | Allied Advanced Technologies (Aat) | 1988-07-15 |
| BREATHE WITH EEZ (NASAL DILATOR) (K874089) | Breathe With Eez Corp. | 1987-12-23 |
| NOZEES NOSTRIL DILATOR (K862406) | Nozees Co. | 1986-09-19 |
Track LWF automatically
Every clearance here is in the API, with alerts when new ones post.