Breathe Right
FDA 510(k) K921220 · Cns, Inc.
510(k) numberK921220
Submission
- Device name
- Breathe Right
- Applicant
- Cns, Inc.
Chanhassen, MN, US - Received
- March 13, 1992
- Decision date
- October 7, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LWF – Dilator, Nasal
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.3900
- Specialty
- Ear, Nose, Throat
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| K181219 | OptiPillows EPAP MaskLWF · Traditional | Cpapnea Medical Supply | 08/03/2018SE |
| K120665 | Invent Snoring DeviceLWF · Traditional | Ventus Medical, Inc. | 06/12/2012SE |
| K040491 | Chin-Up StripLWF · Abbreviated | Dale Miller, Inc. - the Chin-Up Company | 09/10/2004SE |
| K982929 | Maxair Nasal Dilator SystemLWF · Traditional | Hnl Technologies | 09/09/1998SE |
| K963326 | Breathe FitLWF · Traditional | Cambridge Assoc. | 02/12/1997SE |
| K962698 | Acutek's ClearpasageLWF · Traditional | Acutek Adhesive Specialties, Inc. | 09/09/1996SE |
| K962400 | Air Max External Nasal Dilator StripLWF · Traditional | American White Cross, Inc. | 09/09/1996SE |
| K955711 | Breathe Right Nasal StripLWF · Traditional | Cns, Inc. | 05/30/1996SE |
| K954914 | Breathe Right Nasal StripLWF · Traditional | Cns, Inc. | 02/27/1996SE |
| K955233 | Easy Breathing Nasal StripsLWF · Traditional | Corbett Lair, Inc. | 12/21/1995SE |
More from Corbett Lair, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K955711 | Breathe Right Nasal StripLWF · Traditional | 05/30/1996SE |
| K954914 | Breathe Right Nasal StripLWF · Traditional | 02/27/1996SE |
| K953772 | Breathe Right Nasal StripLWF · Traditional | 10/20/1995SE |
| K950273 | Sleep Test(Tm)MNR · Traditional | 09/19/1995SE |
| K912436 | Am-PakGWL · Traditional | 10/18/1991SE |
| K904432 | Sleep I/T-5 and Sleep I/T-8BZQ · Traditional | 07/10/1991SE |
| K910452 | Respi-Pak Rt-PakBZG · Traditional | 04/16/1991SE |
| K901549 | CNS Satellite 100, 200, 1000, 2000 Electroence.GWQ · Traditional | 10/24/1990SE |
| K897107 | Poly G Physiological Data RecorderBXO · Traditional | 03/12/1990SE |
| K860829 | CNS 4/8 and CT 48.1 SoftwareGWS · Traditional | 05/29/1986SE |
Questions and answers
When was Breathe Right cleared by the FDA?
Breathe Right (K921220) received a 510(k) decision of Substantially Equivalent on October 7, 1993, 573 days after the submission was received.
What is the product code of K921220?
The FDA product code is LWF – Dilator, Nasal, a Class I (low risk) device regulated under 21 CFR 874.3900.