510(k) · Cleared
ClearedRinoflow Micronized E.N..T. Wash Sytstem
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 Nov 1, 1996 as substantially equivalent to K821481 (Ethicare Products, 1982) after a 57-day review. Its family tree reaches back 1 generation to 1982.
- Decided
- Nov 1, 1996
- Review
- 57 days
- Class
- Class I
- Product code
- KMA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K821481 (1982). No later device cites it as a predicate yet.
- Root · 1 generation backK821481 Nasal-Throat Spray Irrigation Instrum.Ethicare Products · 1982
- This deviceK963550 Rinoflow Micronized E.N..T. Wash SytstemRespironics, Inc. · 1996
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) | K963550 | Rinoflow Micronized E.N..T. Wash Sytstem | Respironics, Inc. | 1996 | — |
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…1 CFR 874.5550, 77 ETP Common/Usual Name Powered Nasal Irrigator Proprietary Name RinoFlow Micronized E.N.T. Wash System Predicate Devices Puls-ator Irrigator Lavage - K821481 Ethicare P.O. Box 5027 Fort Lauderdale, FL 33310 © 1996 Respironics, Inc. October 21, 1996 Section 12, Page 1 P… | 1982 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K821481.
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?
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 condifions 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:
e Rhinitis
e 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.
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/K963550 · printed Nov 6, 2026
Cite this page
510(k) Report. “K963550: Rinoflow Micronized E.N..T. Wash Sytstem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963550
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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