Irrigator, Powered Nasal
A Powered Nasal Irrigator is a device used in ear, nose, and throat care to mechanically deliver a stream or spray of saline or irrigating solution into the nasal passages, facilitating the removal of mucus, debris, allergens, and crusting to support sinus health. It is classified as FDA Class 1, indicating low risk subject to general controls only without a premarket submission requirement. The product code is KMA and the applicable regulation is 21 CFR 874.5550 in the Ear, Nose, and Throat specialty.
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Basic Information
- Product Code
- KMA
- Device Class
- FDA class 1
- Regulation Number
- 874.5550
- Medical Specialty
- Ear, Nose, Throat
- Review Panel
- EN
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K140542 | NAVAGE NASAL IRRIGATOR, NAVAGE NOSE CLEANER | Jun 27, 2014 | Substantially Equivalent | Rhinosystems, Inc. |
| K973875 | RINOFLOW MICRONIZED E.N.T. WASH SYSTEM | Jan 26, 1998 | Substantially Equivalent | Respironics, Inc. |
| K963550 | RINOFLOW MICRONIZED E.N..T. WASH SYTSTEM | Nov 01, 1996 | Substantially Equivalent | Respironics, Inc. |
| K950078 | MICROFLOW IRRIGATION SYSTEM | Jun 21, 1995 | Substantially Equivalent | Jedmed Instrument Co. |
| K822351 | POWDER BLOWERS | Sep 14, 1982 | Substantially Equivalent | Kelleher Corp. |
FEI Numbers
This FDA classification entry is associated with 95 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 95 registration numbers. Click on an entry to view related FDA registrations.