510(k) · Cleared
ClearedGeonic Nasal Aspirator, Geonic Nasal Cleaner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Geon Corporation · BTA Pump, Portable, Aspiration (Manual Or Powered)
Cleared on Feb 2, 2023 after a 380-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.
- Decided
- Feb 2, 2023
- Review
- 380 days
- Class
- Class II
- Product code
- BTA
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK220126 Geonic Nasal Aspirator, Geonic Nasal CleanerGeon Corporation · 2023
- Descendant · cites it directly · 1 of its ownK243138 Geon (S2) Nasal AspiratorGeon Corporation · 2025
- Descendant · 2 generations on · 0 of its ownK253629 Momcozy Nasal Aspirator (BN007)Shenzhen Root Innovation Technology Co., Ltd. · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K220126 | Geonic Nasal Aspirator, Geonic Nasal Cleaner | Geon Corporation | 2023 | — |
| +1 | K243138 | Geon (S2) Nasal Aspirator | Geon Corporation | 2025 | — |
| +2 | K253629 | Momcozy Nasal Aspirator (BN007) | Shenzhen Root Innovation Technology Co., Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in BTA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new BTA device
- #1 K222547 Electric nasal aspiratorscore 20.7 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243138 | Geon (S2) Nasal Aspirator | 2025 | 1 |
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, K243138 (Geon Corporation, 2025) has gone furthest, with 1 descendant of its own.
How does its category compare?
All BTA devicesBTA Pump, Portable, Aspiration (Manual Or Powered): FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · BTA
7so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · BTA
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BTA
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BTA
13in 2025
MAUDE reports naming product code BTA, 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 | 1 | — | 1 | 13 |
| 2008 | 3 | 135 | 3 | 5 |
| 2009 | 2 | — | 0 | 14 |
| 2010 | 2 | — | 3 | 178 |
| 2011 | 1 | — | 0 | 62 |
| 2012 | 1 | — | 0 | 47 |
| 2013 | 3 | 45 | 0 | 18 |
| 2014 | 3 | 91 | 0 | 399 |
| 2015 | 0 | — | 0 | 15 |
| 2016 | 3 | 149 | 0 | 25 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 4 | 125 | 0 | 17 |
| 2019 | 0 | — | 0 | 14 |
| 2020 | 1 | — | 0 | 10 |
| 2021 | 1 | — | 1 | 9 |
| 2022 | 3 | 58 | 0 | 7 |
| 2023 | 4 | 265 | 0 | 8 |
| 2024 | 5 | 131 | 0 | 13 |
| 2025 | 6 | 87 | 0 | 13 |
| 2026 | 7 | 89 | 0 | — |
What is it indicated for?
Geonic Nasal Aspirator (Model Name: AH2, S1) and Geonic Nasal Cleaner (Model Name: H2) are hand-held, non-invasive, electronic medical devices that provide negative pressure to remove nasal secretions and mucus from children (age 2-12 years old). Geonic Nasal Cleaner (Model Name: H2) additionally provide positive pressure to moisturize the nasal cavities by using saline solution in the form of spray for adults and pediatrics (3 years old). The nasal aspirator and nasal cleaner are intended for over-the-counter (OTC) use at home environment.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K220126 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220126: Geonic Nasal Aspirator, Geonic Nasal Cleaner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220126
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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