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Short answer: “Nasal cones” is a search term for nasal dilators, devices that hold the nostrils open to reduce resistance to airflow. FDA’s regulation (21 CFR 874.3900) defines a nasal dilator as a device for temporary relief of breathing difficulty from structural abnormalities or transient nasal congestion, and recognizes two kinds: an external type that pulls the nostrils open and an internal type, placed inside the nostrils, that pushes them open. In FDA’s database, nasal dilators are Class I devices under product code LWF.
This page gives general product and regulatory information. It is not medical advice and does not describe how to fit or use a device.
Definition and scope
The regulation reads: “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.” It sits in 21 CFR Part 874 (Ear, Nose, and Throat Devices), Subpart D, Prosthetic Devices.
Three phrasings of the same idea turn up in searches and supplier catalogs:
- Nasal cone (also “nose cone”): an everyday name that most closely matches the internal type in the regulation, the one that sits inside the nostrils. The regulation itself does not use the word “cone”.
- Nasal valve dilator: a descriptive name for a dilator that supports the nostril opening. It is not a separate regulatory category.
- Nasal dilator: the regulatory term, covering both internal and external devices.
How the two types work, according to the regulation
The regulation describes the mechanism of each type in one sentence, and nothing further about technique is needed to understand the category.
External nasal dilator
Per 21 CFR 874.3900, an external dilator is “constructed from one or more layers of material upon which a spring material is attached, with a skin adhesive,” and it “acts with a pulling action to open the nares.”
Internal nasal dilator
An internal 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.” This is the type people usually mean by a nasal cone or nasal valve dilator.
Types compared, from the regulation text
| Feature | External dilator | Internal dilator |
|---|---|---|
| Where it sits | On the outside of the nose, attached with a skin adhesive | Inside the nostrils |
| Materials named in the regulation | One or more layers of material with a spring material attached | Metal or plastic |
| Action named in the regulation | Pulling action that opens the nares | Pushes the nostrils open, or gently presses on the columella |
| Common names | Nasal strip, external nasal dilator | Nasal cone, nose cone, nasal valve dilator |
| FDA product code and class | LWF, Class I | LWF, Class I |
The common-name row is an editorial mapping from everyday terms to the regulation’s two descriptions; the other rows quote or paraphrase 21 CFR 874.3900 and the FDA classification database.
FDA classification of nasal dilators
The same regulation and FDA’s product classification database (openFDA, data last updated 2026-10-19, checked 2026-10-30) give the following record for product code LWF:
| Field | Value |
|---|---|
| Device name | Dilator, Nasal |
| Product code | LWF |
| Regulation number | 21 CFR 874.3900 |
| Device class | 1 (general controls) |
| Premarket notification | Exempt from 510(k) procedures in subpart E of part 807, subject to the limitations in 21 CFR 874.9 |
| Review panel | Ear, Nose, and Throat |
| Implant flag | N |
| Life-sustain or support flag | N |
| GMP-exempt flag | N |
| Summary malfunction reporting | Eligible |
The classification database also holds older 510(k) records under LWF, such as one for an external nasal dilator strip with a 1996 decision date. openFDA states that its data are unvalidated and are not for medical decisions.
Where it matters for labs, clinics and supply decisions
- Looking a product up. Searching FDA’s classification database for product code LWF returns the category record above, which lets staff confirm that a product described as a nasal dilator falls under 21 CFR 874.3900 rather than another ear, nose and throat regulation.
- Reading the class correctly. Class I with a 510(k) exemption is a statement about premarket notification, and the exemption is subject to the limits in 21 CFR 874.9. The record’s GMP-exempt flag is “N”, so the quality system requirements are not shown as exempted for this product code.
- Staying inside the intended use. The regulation limits the category to temporary relief of breathing difficulty from structural abnormalities or transient congestion. A product labelled for any other purpose is outside this definition and needs its own regulatory check.
- Registration status. Whether a manufacturer is an FDA-registered establishment says something different from product classification; see FDA registered establishment: what it means and doesn’t mean.
For another Class I device page written the same way, see 128 Hz tuning fork: Class I device, use and accuracy.
Common misunderstandings
A nasal cone is not a nasal splint
A nasal dilator is the device defined in 21 CFR 874.3900. A nasal splint is a different product with different intent, and the two are covered separately; see nasal splint and, for instruments used in ear, nose and throat surgery, see ENT surgical instruments.
The regulation does not cover sleep apnea or snoring treatment
The text of 21 CFR 874.3900 speaks only of temporary relief of breathing difficulty from structural abnormalities or transient congestion. It makes no statement about sleep apnea, snoring or any therapy, and this page makes none either.
“Class I” does not mean “unregulated”
Class I devices remain subject to general controls, and for this product code the GMP-exempt flag is “N”.
FAQ
What is a nasal dilator?
Under 21 CFR 874.3900 it is a device intended for temporary relief of breathing difficulty from structural abnormalities or transient nasal congestion; it decreases airway resistance and increases nasal airflow. It may be external (adhesive, pulling action) or internal (placed in the nostrils, pushing action).
What is a nasal valve dilator?
It is a descriptive name for a dilator that supports the nostril opening. For classification it falls in the same nasal dilator category, product code LWF, Class I.
What are nasal cones?
“Nasal cones” or “nose cones” is an everyday term most closely matching the internal nasal dilator in the regulation: a metal or plastic device placed inside the nostrils that pushes them open or gently presses on the columella.
Sources
- 21 CFR 874.3900, Nasal dilator (Cornell Legal Information Institute copy of the CFR, 64 FR 10949, March 8, 1999): law.cornell.edu/cfr/text/21/874.3900, checked 2026-10-30.
- openFDA device classification, product code LWF: api.fda.gov/device/classification.json?search=product_code:LWF, data last updated 2026-10-19, checked 2026-10-30.
