LWF · Dilator, Nasal
Ear, Nose, Throat · 21 CFR 874.3900 · Class 1
Overview
| Product Code | LWF |
|---|---|
| Device Name | Dilator, Nasal |
| Regulation | 21 CFR 874.3900 |
| Device Class | Class 1 |
| Review Panel | Ear, Nose, Throat |
Identification
A nasal dilator is a device intended to provide temporary relief from transient causes of breathing difficulties resulting from structural abnormalities and/or transient causes of nasal congestion associated with reduced nasal airflow. The device decreases airway resistance and increases nasal airflow. The external nasal dilator is constructed from one or more layers of material upon which a spring material is attached, with a skin adhesive applied to adhere to the skin of the nose; it acts with a pulling action to open the nares. The internal nasal dilator is constructed from metal or plastic and is placed inside the nostrils; it acts by pushing the nostrils open or by gently pressing on the columella.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.
Recent Cleared Devices (20 of 20)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K181219 | OptiPillows EPAP Mask | Cpapnea Medical Supply | Aug 3, 2018 | SESE |
| K120665 | INVENT SNORING DEVICE | Ventus Medical, Inc. | Jun 12, 2012 | SESE |
| K040491 | CHIN-UP STRIP | Dale Miller, Inc. - the Chin-Up Company | Sep 10, 2004 | SESE |
| K982929 | MAXAIR NASAL DILATOR SYSTEM | Hnl Technologies | Sep 9, 1998 | SESE |
| K963326 | BREATHE FIT | Cambridge Assoc. | Feb 12, 1997 | SESE |
| K962698 | ACUTEK'S CLEARPASAGE | Acutek Adhesive Specialties, Inc. | Sep 9, 1996 | SESE |
| K962400 | AIR MAX EXTERNAL NASAL DILATOR STRIP | American White Cross, Inc. | Sep 9, 1996 | SESE |
| K955711 | BREATHE RIGHT NASAL STRIP | Cns, Inc. | May 30, 1996 | SESE |
| K954914 | BREATHE RIGHT NASAL STRIP | Cns, Inc. | Feb 27, 1996 | SESE |
| K955233 | EASY BREATHING NASAL STRIPS | Corbett Lair, Inc. | Dec 21, 1995 | SESE |
| K953042 | E-Z BREATHERS | E-Z Kare Good Health Systems, Inc. | Dec 8, 1995 | SESE |
| K942025 | BURGET NASAL STENT | Bivona Medical Technologies | Oct 27, 1995 | SESE |
| K953772 | BREATHE RIGHT NASAL STRIP | Cns, Inc. | Oct 20, 1995 | SESE |
| K954252 | EASY BREATHING NASAL STRIPS | Corbett Lair, Inc. | Oct 18, 1995 | SESE |
| K951644 | ACUTEK'S CLEARPASSAGE | Acutek Adhesive Specialties, Inc. | Jul 3, 1995 | SESE |
| K921220 | BREATHE RIGHT | Cns, Inc. | Oct 7, 1993 | SESE |
| K904290 | NOZOVENT, NASAL DILATOR | Wpm Intl AB Intl Trade & Managemet Consulting | Aug 20, 1991 | SESE |
| K882131 | NOSE BRACE | Allied Advanced Technologies (Aat) | Jul 15, 1988 | SESE |
| K874089 | BREATHE WITH EEZ (NASAL DILATOR) | Breathe With Eez Corp. | Dec 23, 1987 | SESE |
| K862406 | NOZEES NOSTRIL DILATOR | Nozees Co. | Sep 19, 1986 | SESE |
Top Applicants
- Cns, Inc. — 4 clearances
- Corbett Lair, Inc. — 2 clearances
- Acutek Adhesive Specialties, Inc. — 2 clearances
- Wpm Intl AB Intl Trade & Managemet Consulting — 1 clearance
- Ventus Medical, Inc. — 1 clearance
