510(k) · Cleared
ClearedBaby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021)
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 15, 2026 as substantially equivalent to K244033 (Shenzhen Desida Technology Co., Ltd., 2025) and 2 other predicates after a 119-day review. Its family tree reaches back 9 generations to 1994.
- Decided
- May 15, 2026
- Review
- 119 days
- Class
- Class II
- Product code
- BTA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K935218 (1994). 14 ancestors in all, the oldest K821481 (1982). No later device cites it as a predicate yet.
- Root · 9 generations backK935218 Schuco-Vac Model 178Schuco, Inc. · 1994
- 5 generations between
- 3 generations backK222547 Electric nasal aspiratorShenzhen Xinlianfeng Technology Co.,Ltd · 2022
- 2 generations backK233901 Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA006…Shenzhen Desida Technology Co., Ltd. · 2024
- 1 generation backK244033 Electric Nasal Aspirator…Shenzhen Desida Technology Co., Ltd. · 2025
- This deviceK260134 Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D…Shenzhen Root Innovation Technology Co., Ltd. · 2026
Show all 9 generations
- Root · 9 generations backK935218 Schuco-Vac Model 178Schuco, Inc. · 1994
- 8 generations backK982304 Devilbiss Suction UnitSunrise Medical Hhg, Inc. · 1998 · Recalled
- 7 generations backK063448 Emg AC/DC Suction UnitEmg Technology Co., Ltd. · 2006
- 6 generations backK082762 Aardvark Nasal Irrigation and Aspiration DeviceAardvark Medical · 2008
- 5 generations backK090379 Avita Nasal Aspirator, Model, NS1 SeriesAvita Corporation · 2010
- 4 generations backK180863 FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal AspiratorTaidoc Technology Corporation · 2018
- 3 generations backK222547 Electric nasal aspiratorShenzhen Xinlianfeng Technology Co.,Ltd · 2022
- 2 generations backK233901 Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA006…Shenzhen Desida Technology Co., Ltd. · 2024
- 1 generation backK244033 Electric Nasal Aspirator…Shenzhen Desida Technology Co., Ltd. · 2025
- This deviceK260134 Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D…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 |
|---|---|---|---|---|---|
| −9 | K935218 | Schuco-Vac Model 178 | Schuco, Inc. | 1994 | — |
| −8 | K982304 | Devilbiss Suction Unit | Sunrise Medical Hhg, Inc. | 1998 | 3 |
| −7 | K063448 | Emg AC/DC Suction Unit | Emg Technology Co., Ltd. | 2006 | — |
| −6 | K082762 | Aardvark Nasal Irrigation and Aspiration Device | Aardvark Medical | 2008 | — |
| −5 | K090379 | Avita Nasal Aspirator, Model, NS1 Series | Avita Corporation | 2010 | — |
| −4 | K180863 | FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Aspirator | Taidoc Technology Corporation | 2018 | — |
| −3 | K222547 | Electric nasal aspirator | Shenzhen Xinlianfeng Technology Co.,Ltd | 2022 | — |
| −2 | K233901 | Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA006, NASA008… | Shenzhen Desida Technology Co., Ltd. | 2024 | — |
| −1 | K244033 | Electric Nasal Aspirator… | Shenzhen Desida Technology Co., Ltd. | 2025 | — |
| 0 (this device) | 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 |
| 1995 | 1 | 0 |
| 1998 | 2 | 0 |
| 2024 | 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? (3)
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 |
|---|---|---|---|
| * | K244033 | Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA610)Summary page 5…evice and Reference Device Predicate # Predicate Trade Name (Primary Predicate is listed Product Code first) Product K244033 Electric Nasal Aspirator BTA K241852 Nasal Aspirator（NS13）… | 2025 |
| * | K241852 | Nasal Aspirator (NS 13)Summary page 5…ed Product Code first) Product K244033 Electric Nasal Aspirator BTA K241852 Nasal Aspirator（NS13） BTA, KMA K981602 DeVilbiss Model 6305D He… | 2024 |
| * | K981602 | Devilbiss Model 6305D Heavy Duty AC AspiratorSummary page 5…Nasal Aspirator BTA K241852 Nasal Aspirator（NS13） BTA, KMA K981602 DeVilbiss Model 6305D Heavy Duty AC Aspirator BTA Ⅳ. Device Description The Baby Nasal Aspir… | 1998 |
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 9 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 14 ancestors has a recall of any class.
- 1 other device also cites its predicate K244033.
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 BNO06 series (BNO06, BNO06-A, BNO06-B, BNO06-C, BNO06-D, BNO2) is intended for intermittent removal of nasal secretions and mucus from children (age 2-12 years old). This device is used in a home environment.
The BNO08 series (BNO08, BNO08-A, BNO08-B, BNO08-C, BNO08-D, BC-021) is intended for intermittent removal of nasal secretions and mucus from children (age 2-12 years old). This device is used in a 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 as stated in the FDA summary.
https://510kreport.com/device/K260134 · printed Nov 5, 2026
Cite this page
510(k) Report. “K260134: Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K260134
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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