Product code KMA
- Device name
- Irrigator, Powered Nasal
- Medical specialty
- Ear, Nose, Throat
- Device class
- 1
- Regulation number
- 874.5550
- Review panel
- EN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K140542 | NAVAGE NASAL IRRIGATOR, NAVAGE NOSE CLEANER | Rhinosystems, Inc. | 2014-06-27 |
| K973875 | RINOFLOW MICRONIZED E.N.T. WASH SYSTEM | Respironics, Inc. | 1998-01-26 |
| K963550 | RINOFLOW MICRONIZED E.N..T. WASH SYTSTEM | Respironics, Inc. | 1996-11-01 |
| K950078 | MICROFLOW IRRIGATION SYSTEM | Jedmed Instrument Co. | 1995-06-21 |
| K822351 | POWDER BLOWERS | Kelleher Corp. | 1982-09-14 |
Related GUDID Devices#
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|---|---|---|---|
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| 00763000548797 | Hydrodebrider | MEDTRONIC XOMED, INC. | 2026-02-14 |
| 00057475491505 | BIOS Diagnostics | Thermor Ltd | 2026-01-19 |
| 00763000435905 | Hydrodebrider™ | MEDTRONIC XOMED, INC. | 2025-11-22 |
| 06947656114610 | BERRCOM | Guangzhou Berrcom Medical Device Co., Ltd | 2025-10-13 |
| 00850027492957 | Naväge | Rhinosystems, Inc. | 2025-07-08 |
| 00805106849603 | XTREME | Xtreme Personal Care Inc. | 2025-04-20 |
| 00850044118793 | iHealth | iHealth Labs Inc. | 2024-12-10 |
| 00850044118847 | iHealth | iHealth Labs Inc. | 2024-11-18 |
| 00850044118861 | iHealth | iHealth Labs Inc. | 2024-10-30 |
| 00767056181533 | HealthSmart | D-M-S HOLDINGS, INC. | 2024-09-25 |
| 00858492004958 | Naväge | Rhinosystems, Inc. | 2024-06-20 |
| 00057475160517 | BIOS Diagnostics | Thermor Ltd | 2024-06-17 |
| 06947656115839 | BERRCOM | Guangzhou Berrcom Medical Device Co., Ltd | 2024-06-12 |
| 00767056181526 | HealthSmart | D-M-S HOLDINGS, INC. | 2024-01-26 |
| 00767056181472 | Health Smart | Guangzhou Berrcom Medical Device Co., Ltd | 2024-01-16 |
| 06975983273021 | Momcozy | Shenzhen Lutejiacheng Supply Chain Management Co., Ltd. | 2024-01-10 |
| 06947656115181 | SWINGMED | Guangzhou Berrcom Medical Device Co., Ltd | 2024-01-09 |
| 06947656114719 | Berrcom | Guangzhou Berrcom Medical Device Co., Ltd | 2023-05-22 |
| 00032884203215 | """Evenflo® QuickAction™ Electric Nasal Aspirator """ | Evenflo Company, Inc. | 2022-12-08 |
| 00328785002959 | Braun | KAZ USA, INC. | 2021-10-15 |
| 00850024759138 | BREATHE COMFORT | Slv Pharmaceuticals LLC | 2020-11-18 |
| 00328785006162 | Braun | KAZ USA, INC. | 2020-09-29 |
| 00858492004224 | Naväge | Rhinosystems, Inc. | 2020-02-28 |
| 00858492004644 | Naväge | Rhinosystems, Inc. | 2020-02-28 |
| 00328785002409 | Braun | KAZ USA, INC. | 2019-11-01 |
| 00850632007508 | Easy Air Mini Sinus Irrigation System | HOME AIDE DIAGNOSTICS, INC. | 2019-09-20 |
| 00858492004545 | Naväge | Rhinosystems, Inc. | 2018-08-15 |
| 00858492004002 | Naväge | Rhinosystems, Inc. | 2016-09-21 |