510(k) · Cleared
ClearedRinoflow Micronized E.N.T. Wash System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respironics, Inc. · KMA Irrigator, Powered Nasal
Cleared on Jan 26, 1998 as substantially equivalent to K821481 (Ethicare Products, 1982) after a 108-day review. Its family tree reaches back 1 generation to 1982. 17 later devices descend from it.
- Decided
- Jan 26, 1998
- Review
- 108 days
- Class
- Class I
- Product code
- KMA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K821481 (1982). 17 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK821481 Nasal-Throat Spray Irrigation Instrum.Ethicare Products · 1982
- This deviceK973875 Rinoflow Micronized E.N.T. Wash SystemRespironics, Inc. · 1998
- Descendant · cites it directly · 15 of its ownK082762 Aardvark Nasal Irrigation and Aspiration DeviceAardvark Medical · 2008
- Descendant · 2 generations on · 13 of its ownK090379 Avita Nasal Aspirator, Model, NS1 SeriesAvita Corporation · 2010
- Descendant · 3 generations on · 10 of its ownK180863 FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal AspiratorTaidoc Technology Corporation · 2018
- Descendant · 3 generations on · 9 of its ownK222547 Electric nasal aspiratorShenzhen Xinlianfeng Technology Co.,Ltd · 2022
- Descendant · 4 generations on · 3 of its ownK233901 Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA006…Shenzhen Desida Technology Co., Ltd. · 2024
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K082762Aardvark Nasal Irrigation and Aspiration DeviceAardvark Medical · 2008 · cites it directly15descendants
- K090379Avita Nasal Aspirator, Model, NS1 SeriesAvita Corporation · 2010 · 2 generations on13descendants
- K180863FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal AspiratorTaidoc Technology Corporation · 2018 · 3 generations on10descendants
- K222547Electric nasal aspiratorShenzhen Xinlianfeng Technology Co.,Ltd · 2022 · 3 generations on9descendants
- K233901Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA006, NASA008, NASA009)Shenzhen Desida Technology Co., Ltd. · 2024 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K821481 | Nasal-Throat Spray Irrigation Instrum. | Ethicare Products | 1982 | — |
| 0 (this device) | K973875 | Rinoflow Micronized E.N.T. Wash System | Respironics, Inc. | 1998 | — |
| +1 | K082762 | Aardvark Nasal Irrigation and Aspiration Device | Aardvark Medical | 2008 | — |
| +2 | K090379 | Avita Nasal Aspirator, Model, NS1 Series | Avita Corporation | 2010 | — |
| +3 | K180863 | FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Aspirator | Taidoc Technology Corporation | 2018 | — |
| +3 | K222547 | Electric nasal aspirator | Shenzhen Xinlianfeng Technology Co.,Ltd | 2022 | — |
| +4 | K233901 | Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA006, NASA008… | Shenzhen Desida Technology Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 4 | 0 |
| 2025 | 2 | 0 |
| 2026 | 5 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KMA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K821481 | Nasal-Throat Spray Irrigation Instrum.Summary page 1…Inc. 1001 Murry Ridge Drive Murrysville, PA 15668 21 CFR 874.5550, 77 KMA Powered Nasal Irrigator RinoFlow Micronized E.N.T. Wash System Puls-ator Irrigator Lavage - K821481 Ethicare P.O. Box 5027 Fort Lauderdale, FL. 33310 © October9,1997 ~ Section 12, Page 10f5 Premarket Notificati… | 1982 |
What descends from it? (17)
See all 172 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All KMA devicesKMA Irrigator, Powered Nasal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KMA
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · KMA
Too few KMA 510(k)s in any year since 2007 to give a median.
Recalls per year · KMA
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KMA
3in 2025
MAUDE reports naming product code KMA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 1 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The RinoFlow Micronized E.N.T. Wash System aerosolizes solutions intended for nasal and sinus irrigation and humidification of the upper respiratory tract. RinoFlow is used to treat conditions and disorders of the upper respiratory tract where homeostasis of the nasal mucosa is disturbed, resulting in symptoms such as catarrh, and mucopurulent or crusty secretions. Such conditions and disorders include: * Rhinitis (as a symptom of colds, allergies, etc.)…
Read the full statement (117 words)
The RinoFlow Micronized E.N.T. Wash System aerosolizes solutions intended for nasal and sinus irrigation and humidification of the upper respiratory tract. RinoFlow is used to treat conditions and disorders of the upper respiratory tract where homeostasis of the nasal mucosa is disturbed, resulting in symptoms such as catarrh, and mucopurulent or crusty secretions. Such conditions and disorders include:
* Rhinitis (as a symptom of colds, allergies, etc.)
* Both Acute and Chronic Sinusitis
RinoFlow Micronized E.N.T. Wash System should be used with a physiological saline solution. "Tap" water is not recommended.
RinoFlow Micronized E.N.T. Wash System is intended to be used by adults and pediatrics (age >3) in the home or doctor’s office, and is available over-the-counter.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973875 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973875: Rinoflow Micronized E.N.T. Wash System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973875
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026