510(k) · Cleared
ClearedAardvark Nasal Irrigation and Aspiration Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aardvark Medical · JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered
Cleared on Nov 12, 2008 as substantially equivalent to K973875 (Respironics, Inc., 1998) and 2 other predicates after a 51-day review. Its family tree reaches back 3 generations to 1994. 15 later devices descend from it.
- Decided
- Nov 12, 2008
- Review
- 51 days
- Class
- Class II
- Product code
- JCX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K935218 (1994). 5 ancestors in all, the oldest K821481 (1982). 15 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK935218 Schuco-Vac Model 178Schuco, Inc. · 1994
- 2 generations backK982304 Devilbiss Suction UnitSunrise Medical Hhg, Inc. · 1998 · Recalled
- 1 generation backK063448 Emg AC/DC Suction UnitEmg Technology Co., Ltd. · 2006
- This deviceK082762 Aardvark Nasal Irrigation and Aspiration DeviceAardvark Medical · 2008
- Descendant · cites it directly · 13 of its ownK090379 Avita Nasal Aspirator, Model, NS1 SeriesAvita Corporation · 2010
- Descendant · 2 generations on · 10 of its ownK180863 FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal AspiratorTaidoc Technology Corporation · 2018
- Descendant · 2 generations on · 9 of its ownK222547 Electric nasal aspiratorShenzhen Xinlianfeng Technology Co.,Ltd · 2022
- Descendant · 3 generations on · 3 of its ownK233901 Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA006…Shenzhen Desida Technology Co., Ltd. · 2024
- Descendant · 4 generations on · 2 of its ownK244033 Electric Nasal Aspirator…Shenzhen Desida Technology Co., Ltd. · 2025
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K090379Avita Nasal Aspirator, Model, NS1 SeriesAvita Corporation · 2010 · cites it directly13descendants
- K180863FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal AspiratorTaidoc Technology Corporation · 2018 · 2 generations on10descendants
- K222547Electric nasal aspiratorShenzhen Xinlianfeng Technology Co.,Ltd · 2022 · 2 generations on9descendants
- K233901Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA006, NASA008, NASA009)Shenzhen Desida Technology Co., Ltd. · 2024 · 3 generations on3descendants
- K244033Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA610)Shenzhen Desida Technology Co., Ltd. · 2025 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K935218 | Schuco-Vac Model 178 | Schuco, Inc. | 1994 | — |
| −2 | K982304 | Devilbiss Suction Unit | Sunrise Medical Hhg, Inc. | 1998 | 3 |
| −1 | K063448 | Emg AC/DC Suction Unit | Emg Technology Co., Ltd. | 2006 | — |
| 0 (this device) | K082762 | Aardvark Nasal Irrigation and Aspiration Device | Aardvark Medical | 2008 | — |
| +1 | K090379 | Avita Nasal Aspirator, Model, NS1 Series | Avita Corporation | 2010 | — |
| +2 | K180863 | FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Aspirator | Taidoc Technology Corporation | 2018 | — |
| +2 | K222547 | Electric nasal aspirator | Shenzhen Xinlianfeng Technology Co.,Ltd | 2022 | — |
| +3 | K233901 | Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA006, NASA008… | Shenzhen Desida Technology Co., Ltd. | 2024 | — |
| +4 | K244033 | Electric Nasal Aspirator… | Shenzhen Desida Technology Co., Ltd. | 2025 | — |
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 |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 4 | 0 |
| 2025 | 2 | 0 |
| 2026 | 5 | 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 JCX? 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 JCX device
- #1 K250964 Protable Phlegm Suction Unit (JMA D01)score 12.2 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K973875 | Rinoflow Micronized E.N.T. Wash SystemSummary page 1…ble Suction 878.4780 Class II Predicate Devices: Deee Name MaiOMufaeturer K Number Rhinoflow Respironics K973875 Micronized ENT Wash System Orwell Fluid Cardinal Health K989845 Collections and Dis… | 1998 |
| Kept off the family tree | K989845 | Orwell Fluid Collections and Disposal System Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…K Number Rhinoflow Respironics K973875 Micronized ENT Wash System Orwell Fluid Cardinal Health K989845 Collections and Disposal System DeVilbiss Sunrise Medical K982304 Suction Device… | |
| * | K982304 | Devilbiss Suction UnitSummary page 1…sh System Orwell Fluid Cardinal Health K989845 Collections and Disposal System DeVilbiss Sunrise Medical K982304 Suction Device The EMG EMG Technology K063448 suction Unit Company Descr… | 1998 |
| * | K063448 | Emg AC/DC Suction UnitSummary page 1…ctions and Disposal System DeVilbiss Sunrise Medical K982304 Suction Device The EMG EMG Technology K063448 suction Unit Company Description of Device: The Aardvark device is designed to make nasal and sinus lavage ea… | 2006 |
What descends from it? (15)
See all 152 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 14 years and passes through 4 companies; a new generation was cleared every 4.5 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K090379 (Avita Corporation, 2010) has gone furthest, with 13 descendants of its own.
- 1 other device also cites its predicate K973875.
How does its category compare?
All JCX devicesJCX Apparatus, Suction, Ward Use, Portable, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · JCX
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JCX
30in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JCX
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JCX
45in 2025
MAUDE reports naming product code JCX, 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 | 0 | — | 0 | 48 |
| 2008 | 4 | 43 | 3 | 57 |
| 2009 | 1 | — | 0 | 34 |
| 2010 | 1 | — | 0 | 7 |
| 2011 | 2 | — | 2 | 9 |
| 2012 | 2 | — | 0 | 18 |
| 2013 | 5 | 144 | 2 | 12 |
| 2014 | 4 | 106 | 0 | 68 |
| 2015 | 0 | — | 0 | 118 |
| 2016 | 2 | — | 0 | 119 |
| 2017 | 2 | — | 1 | 102 |
| 2018 | 2 | — | 0 | 170 |
| 2019 | 3 | 30 | 0 | 132 |
| 2020 | 0 | — | 1 | 89 |
| 2021 | 0 | — | 0 | 227 |
| 2022 | 1 | — | 0 | 215 |
| 2023 | 1 | — | 0 | 187 |
| 2024 | 1 | — | 0 | 103 |
| 2025 | 2 | — | 0 | 45 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The Aardvark Medical Device is intended for use in nasal and sinus lavage. The device facilitates instillation of saline into the nasal passage and provides powered suction to either 1) directly evacuate the nasal passage, or 2) to remove the fluid and effluent by aspirating from the opposite nostril in a maneuver similar to the Proetz displacement or Aspiration Irrigation Maneuver. The device is used to treat conditions and disorders of the upper…
Read the full statement (143 words)
The Aardvark Medical Device is intended for use in nasal and sinus lavage. The device facilitates instillation of saline into the nasal passage and provides powered suction to either 1) directly evacuate the nasal passage, or 2) to remove the fluid and effluent by aspirating from the opposite nostril in a maneuver similar to the Proetz displacement or Aspiration Irrigation Maneuver. The device is used to treat conditions and disorders of the upper respiratory tract where homeostasis of the nasal mucosa is disturbed, resulting in symptoms such as catarrh and mucopurulent or crust secretions. Such conditions and disorders include: Rhinitis (as a symptom of colds, allergies, etc.) and both acute and chronic Sinusitis. It can also be used to collect mucus samples for subsequent testing. It is intended for use in adults and children in either the physician's office or in the home.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082762 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082762: Aardvark Nasal Irrigation and Aspiration Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082762
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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