510(k) Report

510(k) · Cleared

Cleared

Electric nasal aspirator

K222547510(k) TraditionalCleared Oct 20, 202258-day reviewClass II21 CFR 878.4780

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Shenzhen Xinlianfeng Technology Co.,Ltd · BTA Pump, Portable, Aspiration (Manual Or Powered)

Cleared on Oct 20, 2022 as substantially equivalent to K180863 (Taidoc Technology Corporation, 2018) and 1 other predicate after a 58-day review. Its family tree reaches back 6 generations to 1994. 9 later devices descend from it.

Decided
Oct 20, 2022
Review
58 days
Class
Class II
Product code
BTA
Recalls
None
Predicates
2

Its longest line of descent runs back 6 generations to K935218 (1994). 8 ancestors in all, the oldest K821481 (1982). 9 later devices descend from it, 5 citing it directly.

  1. Root · 6 generations backK935218 Schuco-Vac Model 178Schuco, Inc. · 1994
  2. 5 generations backK982304 Devilbiss Suction UnitSunrise Medical Hhg, Inc. · 1998 · Recalled
  3. 4 generations backK063448 Emg AC/DC Suction UnitEmg Technology Co., Ltd. · 2006
  4. 3 generations backK082762 Aardvark Nasal Irrigation and Aspiration DeviceAardvark Medical · 2008
  5. 2 generations backK090379 Avita Nasal Aspirator, Model, NS1 SeriesAvita Corporation · 2010
  6. 1 generation backK180863 FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal AspiratorTaidoc Technology Corporation · 2018
  7. This deviceK222547 Electric nasal aspiratorShenzhen Xinlianfeng Technology Co.,Ltd · 2022
  8. Descendant · cites it directly · 3 of its ownK233901 Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA006…Shenzhen Desida Technology Co., Ltd. · 2024
  9. Descendant · 2 generations on · 2 of its ownK244033 Electric Nasal Aspirator…Shenzhen Desida Technology Co., Ltd. · 2025
  10. Descendant · cites it directly · 1 of its ownK250697 Electric Nasal Aspirator (BC026, BC025, BC023)Shenzhen Kingboom Technology Co., Ltd. · 2025
  11. Descendant · cites it directly · 1 of its ownK241202 Electric nasal aspirator (HTD2601US)Hetaida Technology Co., Ltd. · 2024
  12. Descendant · 3 generations on · 0 of its ownK260134 Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D…Shenzhen Root Innovation Technology Co., Ltd. · 2026

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2024: 32025: 22026: 4
2024high 4 (2026) · low 2 (2025)2026

Most influential descendants

Showing 5 of 9 · See all
  • K233901Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA006, NASA008, NASA009)Shenzhen Desida Technology Co., Ltd. · 2024 · cites it directly3descendants
  • K244033Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA610)Shenzhen Desida Technology Co., Ltd. · 2025 · 2 generations on2descendants
  • K250697Electric Nasal Aspirator (BC026, BC025, BC023)Shenzhen Kingboom Technology Co., Ltd. · 2025 · cites it directly1descendant
  • K241202Electric nasal aspirator (HTD2601US)Hetaida Technology Co., Ltd. · 2024 · cites it directly1descendant
  • K260134Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A…Shenzhen Root Innovation Technology Co., Ltd. · 2026 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K935218Schuco-Vac Model 178Schuco, Inc.1994—
−5K982304Devilbiss Suction UnitSunrise Medical Hhg, Inc.19983
−4K063448Emg AC/DC Suction UnitEmg Technology Co., Ltd.2006—
−3K082762Aardvark Nasal Irrigation and Aspiration DeviceAardvark Medical2008—
−2K090379Avita Nasal Aspirator, Model, NS1 SeriesAvita Corporation2010—
−1K180863FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal AspiratorTaidoc Technology Corporation2018—
0 (this device)K222547Electric nasal aspiratorShenzhen Xinlianfeng Technology Co.,Ltd2022—
+1K233901Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA006, NASA008…Shenzhen Desida Technology Co., Ltd.2024—
+2K244033Electric Nasal Aspirator…Shenzhen Desida Technology Co., Ltd.2025—
+1K250697Electric Nasal Aspirator (BC026, BC025, BC023)Shenzhen Kingboom Technology Co., Ltd.2025—
+1K241202Electric nasal aspirator (HTD2601US)Hetaida Technology Co., Ltd.2024—
+3K260134Baby 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 clearedDevicesWith a Class I recall
198210
199810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202430
202520
202640
FIG. 1 — Lineage of K222547, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K244033 Electric Nasal Aspirator…score 17.4 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K180863FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Aspirator
Summary page 5
…gally Marketed Aspirator, NAS100 (Electronic Model NS1 Device Nasal Aspirator, TD-7601) 510(K) Number K180863 K090379 4. Description of Device Electric nasal aspirator consists of main unit, and su…
Taidoc Technology Corporation2018—
*K090379Avita Nasal Aspirator, Model, NS1 Series
Summary page 5
…lectronic Model NS1 Device Nasal Aspirator, TD-7601) 510(K) Number K180863 K090379 4. Description of Device Electric nasal aspirator consists of main unit, and suction portion working together as one unit. Th…
Avita Corporation2010—

What descends from it? (9)

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K233901Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA006, NASA008, NASA009)Shenzhen Desida Technology Co., Ltd.20243
K250697Electric Nasal Aspirator (BC026, BC025, BC023)Shenzhen Kingboom Technology Co., Ltd.20251
K241202Electric nasal aspirator (HTD2601US)Hetaida Technology Co., Ltd.20241
K260473Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B)Shenzhen Kingboom Technology Co., Ltd.20260
K242028Nasal Aspirator (BC-021, BC-022, BC-023, BC-024, BC-025, BC-026)Dongguanshi Yiyingmei Technology Co., Ltd.20240

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 28 years and passes through 7 companies; a new generation was cleared every 4.5 years on median.
  • 1 of the 8 ancestors has a recall of any class.
  • Of its descendants, K233901 (Shenzhen Desida Technology Co., Ltd., 2024) has gone furthest, with 3 descendants of its own.

How does its category compare?

All BTA devices

BTA Pump, Portable, Aspiration (Manual Or Powered): FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.

FDA decisions per year · BTA

7so far in 2026, the most since 2007

2007: 12008: 32009: 22010: 22011: 12012: 12013: 32014: 32016: 32017: 12018: 42020: 12021: 12022: 32023: 42024: 52025: 62026 (partial year): 7
2007high 7 (2026) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BTA

87in 2025

2008: 135 days median2013: 45 days median2014: 91 days median2016: 149 days median2018: 125 days median2022: 58 days median2023: 265 days median2024: 131 days median2025: 87 days median2026 (partial year): 89 days median
2007high 265 (2023) · low 45 (2013)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · BTA

1in 2021

2007: 12008: 32010: 32021: 1
2007high 3 (2008) · low 0 (2009)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · BTA

13in 2025

2007: 132008: 52009: 142010: 1782011: 622012: 472013: 182014: 3992015: 152016: 252017: 42018: 172019: 142020: 102021: 92022: 72023: 82024: 132025: 13
2007high 399 (2014) · low 4 (2017)2025

MAUDE reports naming product code BTA, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—113
2008313535
20092—014
20102—3178
20111—062
20121—047
2013345018
20143910399
20150—015
20163149025
20171—04
20184125017
20190—014
20201—010
20211—19
202235807
2023426508
20245131013
2025687013
20267890—

What is it indicated for?

The Electronic Nasal Aspirator 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.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K222547: Electric nasal aspirator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K222547

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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