510(k) · Cleared
ClearedNasal-Throat Spray Irrigation Instrum.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ethicare Products · ETP Stimulator, Caloric-Water
Cleared on Jun 14, 1982 after a 27-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 19 later devices descend from it.
- Decided
- Jun 14, 1982
- Review
- 27 days
- Class
- Class I
- Product code
- ETP
- Recalls
- None
- Predicates
- 0
19 later devices descend from it, 2 citing it directly.
- This deviceK821481 Nasal-Throat Spray Irrigation Instrum.Ethicare Products · 1982
- Descendant · cites it directly · 17 of its ownK973875 Rinoflow Micronized E.N.T. Wash SystemRespironics, Inc. · 1998
- Descendant · 2 generations on · 15 of its ownK082762 Aardvark Nasal Irrigation and Aspiration DeviceAardvark Medical · 2008
- Descendant · 3 generations on · 13 of its ownK090379 Avita Nasal Aspirator, Model, NS1 SeriesAvita Corporation · 2010
- Descendant · 4 generations on · 10 of its ownK180863 FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal AspiratorTaidoc Technology Corporation · 2018
- Descendant · 4 generations on · 9 of its ownK222547 Electric nasal aspiratorShenzhen Xinlianfeng Technology Co.,Ltd · 2022
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K973875Rinoflow Micronized E.N.T. Wash SystemRespironics, Inc. · 1998 · cites it directly17descendants
- K082762Aardvark Nasal Irrigation and Aspiration DeviceAardvark Medical · 2008 · 2 generations on15descendants
- K090379Avita Nasal Aspirator, Model, NS1 SeriesAvita Corporation · 2010 · 3 generations on13descendants
- K180863FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal AspiratorTaidoc Technology Corporation · 2018 · 4 generations on10descendants
- K222547Electric nasal aspiratorShenzhen Xinlianfeng Technology Co.,Ltd · 2022 · 4 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K821481 | Nasal-Throat Spray Irrigation Instrum. | Ethicare Products | 1982 | — |
| +1 | K973875 | Rinoflow Micronized E.N.T. Wash System | Respironics, Inc. | 1998 | — |
| +2 | K082762 | Aardvark Nasal Irrigation and Aspiration Device | Aardvark Medical | 2008 | — |
| +3 | K090379 | Avita Nasal Aspirator, Model, NS1 Series | Avita Corporation | 2010 | — |
| +4 | K180863 | FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Aspirator | Taidoc Technology Corporation | 2018 | — |
| +4 | K222547 | Electric nasal aspirator | Shenzhen Xinlianfeng Technology Co.,Ltd | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ETP? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (19)
See all 192 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?
- Of its descendants, K973875 (Respironics, Inc., 1998) has gone furthest, with 17 descendants of its own.
How does its category compare?
All ETP devicesETP Stimulator, Caloric-Water: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ETP
FDA has decided no ETP device since 2007.
Median 510(k) review, days · ETP
Too few ETP 510(k)s in any year since 2007 to give a median.
Recalls per year · ETP
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ETP
No MAUDE report names ETP since 2007.
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 | — | 1 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 1 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K821481 · printed Nov 6, 2026
Cite this page
510(k) Report. “K821481: Nasal-Throat Spray Irrigation Instrum..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K821481
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026