510(k) · Cleared
ClearedNasal Aspirator (NS 13)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Avita Corporation · BTA Pump, Portable, Aspiration (Manual Or Powered)
Cleared on Dec 31, 2024 as substantially equivalent to K090379 (Avita Corporation, 2010) after a 187-day review. Its family tree reaches back 5 generations to 1994. 2 later devices descend from it.
- Decided
- Dec 31, 2024
- Review
- 187 days
- Class
- Class II
- Product code
- BTA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K935218 (1994). 7 ancestors in all, the oldest K821481 (1982). 2 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK935218 Schuco-Vac Model 178Schuco, Inc. · 1994
- 4 generations backK982304 Devilbiss Suction UnitSunrise Medical Hhg, Inc. · 1998 · Recalled
- 3 generations backK063448 Emg AC/DC Suction UnitEmg Technology Co., Ltd. · 2006
- 2 generations backK082762 Aardvark Nasal Irrigation and Aspiration DeviceAardvark Medical · 2008
- 1 generation backK090379 Avita Nasal Aspirator, Model, NS1 SeriesAvita Corporation · 2010
- This deviceK241852 Nasal Aspirator (NS 13)Avita Corporation · 2024
- Descendant · cites it directly · 0 of its ownK253629 Momcozy Nasal Aspirator (BN007)Shenzhen Root Innovation Technology Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK260134 Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D…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 |
|---|---|---|---|---|---|
| −5 | K935218 | Schuco-Vac Model 178 | Schuco, Inc. | 1994 | — |
| −4 | K982304 | Devilbiss Suction Unit | Sunrise Medical Hhg, Inc. | 1998 | 3 |
| −3 | K063448 | Emg AC/DC Suction Unit | Emg Technology Co., Ltd. | 2006 | — |
| −2 | K082762 | Aardvark Nasal Irrigation and Aspiration Device | Aardvark Medical | 2008 | — |
| −1 | K090379 | Avita Nasal Aspirator, Model, NS1 Series | Avita Corporation | 2010 | — |
| 0 (this device) | K241852 | Nasal Aspirator (NS 13) | Avita Corporation | 2024 | — |
| +1 | K253629 | Momcozy Nasal Aspirator (BN007) | Shenzhen Root Innovation Technology Co., Ltd. | 2026 | — |
| +1 | K260134 | Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008… | Shenzhen Root Innovation Technology Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 2 | 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 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? (2)
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 |
|---|---|---|---|
| * | K090379 | Avita Nasal Aspirator, Model, NS1 SeriesSummary page 8…NS1 Series) (Geonic Nasal Cleaner) K number - K090379 NA Classification 21CFR 878.4780… | 2010 |
| * | — | Geonic Nasal Cleaner Named without a submission number |
What descends from it? (2)
2 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?
- The line of descent spans 30 years and passes through 5 companies; a new generation was cleared every 4.5 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K253629 (Shenzhen Root Innovation Technology Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K090379.
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. 2024, 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?
The device is designed for using suction to remove nasal secretion and mucus in Children (age 2~12 years old) at home environment.
The additional spray/irrigation function helps moisten and loosen/soften nasal secretions in Children (over 3 years old), making them easier to aspirate.
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/K241852 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241852: Nasal Aspirator (NS 13).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241852
Report an extraction error
Are you the manufacturer?
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