510(k) Report

510(k) · Cleared

Cleared

Avita Nasal Aspirator, Model, NS1 Series

K090379510(k) TraditionalCleared May 26, 2010463-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

Avita Corporation · BTA Pump, Portable, Aspiration (Manual Or Powered)

Cleared on May 26, 2010 as substantially equivalent to K082762 (Aardvark Medical, 2008) and 1 other predicate after a 463-day review. Its family tree reaches back 4 generations to 1994. 13 later devices descend from it.

Decided
May 26, 2010
Review
463 days
Class
Class II
Product code
BTA
Recalls
None
Predicates
2

Its longest line of descent runs back 4 generations to K935218 (1994). 6 ancestors in all, the oldest K821481 (1982). 13 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 1 other ancestor1982: 1 other ancestor2018: 1 descendant cleared2022: 1 descendant cleared2024: 4 descendants cleared2025: 2 descendants cleared2026: 5 descendants clearedK935218 · Schuco-Vac Model 178 · Schuco, Inc. · 1994K982304 · Devilbiss Suction Unit · Sunrise Medical Hhg, Inc. · 1998 · recalledK063448 · Emg AC/DC Suction Unit · Emg Technology Co., Ltd. · 2006K082762 · Aardvark Nasal Irrigation and Aspiration Device · Aardvark Medical · 200819801990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor3 generations back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 7 descendants3 generations forward: 2 descendants4 generations forward: 1 descendant K082762 · Aardvark Nasal Irrigation and Aspiration Device · Aardvark Medical · 2008K063448 · Emg AC/DC Suction Unit · Emg Technology Co., Ltd. · 2006K982304 · Devilbiss Suction Unit · Sunrise Medical Hhg, Inc. · 1998 · recalledK935218 · Schuco-Vac Model 178 · Schuco, Inc. · 19940
  1. Root · 4 generations backK935218 Schuco-Vac Model 178Schuco, Inc. · 1994
  2. 3 generations backK982304 Devilbiss Suction UnitSunrise Medical Hhg, Inc. · 1998 · Recalled
  3. 2 generations backK063448 Emg AC/DC Suction UnitEmg Technology Co., Ltd. · 2006
  4. 1 generation backK082762 Aardvark Nasal Irrigation and Aspiration DeviceAardvark Medical · 2008
  5. This deviceK090379 Avita Nasal Aspirator, Model, NS1 SeriesAvita Corporation · 2010
  6. Descendant · cites it directly · 10 of its ownK180863 FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal AspiratorTaidoc Technology Corporation · 2018
  7. Descendant · cites it directly · 9 of its ownK222547 Electric nasal aspiratorShenzhen Xinlianfeng Technology Co.,Ltd · 2022
  8. Descendant · 2 generations on · 3 of its ownK233901 Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA006…Shenzhen Desida Technology Co., Ltd. · 2024
  9. Descendant · 3 generations on · 2 of its ownK244033 Electric Nasal Aspirator…Shenzhen Desida Technology Co., Ltd. · 2025
  10. Descendant · cites it directly · 2 of its ownK241852 Nasal Aspirator (NS 13)Avita Corporation · 2024

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2018: 12022: 12024: 42025: 22026: 5
2018high 5 (2026) · low 0 (2019)2026

Most influential descendants

Showing 5 of 13 · See all
  • K180863FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal AspiratorTaidoc Technology Corporation · 2018 · cites it directly10descendants
  • K222547Electric nasal aspiratorShenzhen Xinlianfeng Technology Co.,Ltd · 2022 · cites it directly9descendants
  • K233901Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA006, NASA008, NASA009)Shenzhen Desida Technology Co., Ltd. · 2024 · 2 generations on3descendants
  • K244033Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA610)Shenzhen Desida Technology Co., Ltd. · 2025 · 3 generations on2descendants
  • K241852Nasal Aspirator (NS 13)Avita Corporation · 2024 · cites it directly2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K935218Schuco-Vac Model 178Schuco, Inc.1994—
−3K982304Devilbiss Suction UnitSunrise Medical Hhg, Inc.19983
−2K063448Emg AC/DC Suction UnitEmg Technology Co., Ltd.2006—
−1K082762Aardvark Nasal Irrigation and Aspiration DeviceAardvark Medical2008—
0 (this device)K090379Avita Nasal Aspirator, Model, NS1 SeriesAvita Corporation2010—
+1K180863FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal AspiratorTaidoc Technology Corporation2018—
+1K222547Electric nasal aspiratorShenzhen Xinlianfeng Technology Co.,Ltd2022—
+2K233901Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA006, NASA008…Shenzhen Desida Technology Co., Ltd.2024—
+3K244033Electric Nasal Aspirator…Shenzhen Desida Technology Co., Ltd.2025—
+1K241852Nasal Aspirator (NS 13)Avita Corporation2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198210
199810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201810
202210
202440
202520
202650
FIG. 1 — Lineage of K090379, 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 K222547 Electric nasal aspiratorscore 20.7 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K082762Aardvark Nasal Irrigation and Aspiration Device
Summary page 1
…ery Product Code: 1CX Regulation Number: 21CFR 878.4780 Class II 21CFR 874.5550 Class I The predicate device is the o Aardvark Nasal Irrigation and Aspiration System (K082762) marketed by Aardvark Medical Company. . e DeVilbiss SUCTION UNIT(K982304) marketed by SUNRISE MEDICAL HHG, ING. This device is…
Aardvark Medical2008—
*K982304Devilbiss Suction Unit
Summary page 1
….5550 Class I The predicate device is the o Aardvark Nasal Irrigation and Aspiration System (K082762) marketed by Aardvark Medical Company. . e DeVilbiss SUCTION UNIT(K982304) marketed by SUNRISE MEDICAL HHG, ING. This device is designed for using intermittent suction to remove nasal secretion and mucu…
Sunrise Medical Hhg, Inc.19983

Also cleared against K082762: 1 other device →

What descends from it? (13)

See all 13

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

NumberDeviceApplicantDecidedDescendants
K180863FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal AspiratorTaidoc Technology Corporation201810
K222547Electric nasal aspiratorShenzhen Xinlianfeng Technology Co.,Ltd20229
K241852Nasal Aspirator (NS 13)Avita Corporation20242

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 16 years and passes through 5 companies; a new generation was cleared every 4.5 years on median.
  • 1 of the 6 ancestors has a recall of any class.
  • Of its descendants, K180863 (Taidoc Technology Corporation, 2018) has gone furthest, with 10 descendants of its own.
  • 1 other device also cites its predicate K082762.

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. 2010, 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?

This device is designed for using intermittent suction to remove

nasal secretion and mucus in Children (age 2-12 years old) at home

environment.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Cite this page

510(k) Report. “K090379: Avita Nasal Aspirator, Model, NS1 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090379

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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