510(k) · Cleared
ClearedMomcozy Nasal Aspirator (BN007)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Root Innovation Technology Co., Ltd. · BTA Pump, Portable, Aspiration (Manual Or Powered)
Cleared on May 26, 2026 as substantially equivalent to K243138 (Geon Corporation, 2025) and 1 other predicate after a 188-day review. Its family tree reaches back 6 generations to 1994.
- Decided
- May 26, 2026
- Review
- 188 days
- Class
- Class II
- Product code
- BTA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K935218 (1994). 10 ancestors in all, the oldest K821481 (1982). No later device cites it as a predicate yet.
- Root · 6 generations backK935218 Schuco-Vac Model 178Schuco, Inc. · 1994
- 5 generations backK982304 Devilbiss Suction UnitSunrise Medical Hhg, Inc. · 1998 · Recalled
- 4 generations backK063448 Emg AC/DC Suction UnitEmg Technology Co., Ltd. · 2006
- 3 generations backK082762 Aardvark Nasal Irrigation and Aspiration DeviceAardvark Medical · 2008
- 2 generations backK090379 Avita Nasal Aspirator, Model, NS1 SeriesAvita Corporation · 2010
- 1 generation backK241852 Nasal Aspirator (NS 13)Avita Corporation · 2024
- This deviceK253629 Momcozy Nasal Aspirator (BN007)Shenzhen Root Innovation Technology Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K935218 | Schuco-Vac Model 178 | Schuco, Inc. | 1994 | — |
| −5 | K982304 | Devilbiss Suction Unit | Sunrise Medical Hhg, Inc. | 1998 | 3 |
| −4 | K063448 | Emg AC/DC Suction Unit | Emg Technology Co., Ltd. | 2006 | — |
| −3 | K082762 | Aardvark Nasal Irrigation and Aspiration Device | Aardvark Medical | 2008 | — |
| −2 | K090379 | Avita Nasal Aspirator, Model, NS1 Series | Avita Corporation | 2010 | — |
| −1 | K241852 | Nasal Aspirator (NS 13) | Avita Corporation | 2024 | — |
| 0 (this device) | K253629 | Momcozy Nasal Aspirator (BN007) | 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 |
| 2023 | 1 | 0 |
| 2025 | 1 | 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 |
|---|---|---|---|
| * | K243138 | Geon (S2) Nasal AspiratorSummary page 5…TA, KMA Regulation Number: 878.4780 Device Class: II 3 PREDICATE DEVICE 510(k) Number: K243138 Trade Name: Geon (S2) Nasal Aspirator Manufacturer: Geon Corporation… | 2025 |
| * | K241852 | Nasal Aspirator (NS 13)Summary page 5…Trade Name: Geon (S2) Nasal Aspirator Manufacturer: Geon Corporation 510(k) Number: K241852 Trade Name: Nasal Aspirator (NS 13) Manufacturer: AViTA Corporation… | 2024 |
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?
- The line of descent spans 32 years and passes through 6 companies; a new generation was cleared every 4.5 years on median.
- 1 of the 10 ancestors has a recall of any class.
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. 2026, 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 function helps moisturize and 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/K253629 · printed Nov 5, 2026
Cite this page
510(k) Report. “K253629: Momcozy Nasal Aspirator (BN007).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K253629
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026