Product Code: LWF FDA class 1 21 CFR 874.3900

Dilator, Nasal

Ear, Nose, Throat

The Nasal Dilator (product code LWF) is a small device placed in or around the nasal passage to mechanically widen the nasal airway, aiding in breathing during sleep, exercise, or in cases of nasal congestion or obstruction. Regulated under 21 CFR 874.3900 and classified as a Class 1 device subject only to general controls, it falls under the Ear, Nose, and Throat medical specialty. The device is not exempt from GMP requirements. It is not an implant and is not life-sustaining.

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510(k)s

FEI Numbers

115

Registration Numbers

115

Unique Applicants

Years Active

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Basic Information

Product Code: LWF
Device Class: FDA class 1
Regulation Number: 874.3900
Medical Specialty: Ear, Nose, Throat
Review Panel: EN
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 20 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K181219	OptiPillows EPAP Mask	Aug 03, 2018	Substantially Equivalent	Cpapnea Medical Supply
K120665	INVENT SNORING DEVICE	Jun 12, 2012	Substantially Equivalent	Ventus Medical, Inc.
K040491	CHIN-UP STRIP	Sep 10, 2004	Substantially Equivalent	Dale Miller, Inc. - the Chin-Up Company
K982929	MAXAIR NASAL DILATOR SYSTEM	Sep 09, 1998	Substantially Equivalent	Hnl Technologies
K963326	BREATHE FIT	Feb 12, 1997	Substantially Equivalent	Cambridge Assoc.
K962698	ACUTEK'S CLEARPASAGE	Sep 09, 1996	Substantially Equivalent	Acutek Adhesive Specialties, Inc.
K962400	AIR MAX EXTERNAL NASAL DILATOR STRIP	Sep 09, 1996	Substantially Equivalent	American White Cross, Inc.
K955711	BREATHE RIGHT NASAL STRIP	May 30, 1996	Substantially Equivalent	Cns, Inc.
K954914	BREATHE RIGHT NASAL STRIP	Feb 27, 1996	Substantially Equivalent	Cns, Inc.
K955233	EASY BREATHING NASAL STRIPS	Dec 21, 1995	Substantially Equivalent	Corbett Lair, Inc.
K953042	E-Z BREATHERS	Dec 08, 1995	Substantially Equivalent	E-Z Kare Good Health Systems, Inc.
K942025	BURGET NASAL STENT	Oct 27, 1995	Substantially Equivalent	Bivona Medical Technologies
K953772	BREATHE RIGHT NASAL STRIP	Oct 20, 1995	Substantially Equivalent	Cns, Inc.
K954252	EASY BREATHING NASAL STRIPS	Oct 18, 1995	Substantially Equivalent	Corbett Lair, Inc.
K951644	ACUTEK'S CLEARPASSAGE	Jul 03, 1995	Substantially Equivalent	Acutek Adhesive Specialties, Inc.
K921220	BREATHE RIGHT	Oct 07, 1993	Substantially Equivalent	Cns, Inc.
K904290	NOZOVENT, NASAL DILATOR	Aug 20, 1991	Substantially Equivalent	Wpm Intl AB Intl Trade & Managemet Consulting
K882131	NOSE BRACE	Jul 15, 1988	Substantially Equivalent	Allied Advanced Technologies (Aat)
K874089	BREATHE WITH EEZ (NASAL DILATOR)	Dec 23, 1987	Substantially Equivalent	Breathe With Eez Corp.
K862406	NOZEES NOSTRIL DILATOR	Sep 19, 1986	Substantially Equivalent	Nozees Co.