# K082762: Aardvark Nasal Irrigation and Aspiration Device

- Pathway: 510(k) (Traditional)
- Applicant: Aardvark Medical
- Decided: Nov 12, 2008 after 51 days
- Product code: JCX (Apparatus, Suction, Ward Use, Portable, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 878.4780
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K935218 (1994). 5 ancestors in all.
15 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973875: Rinoflow Micronized E.N.T. Wash System, Respironics, Inc. (1998) Summary page 1.
- K982304: Devilbiss Suction Unit, Sunrise Medical Hhg, Inc. (1998) Summary page 1.
- K063448: Emg AC/DC Suction Unit, Emg Technology Co., Ltd. (2006) Summary page 1.

## Cited in the summary but 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.

## Most influential descendants
- K090379: Avita Nasal Aspirator, Model, NS1 Series (2010), 13 descendants of its own
- K180863: FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Aspirator (2018), 10 descendants of its own
- K222547: Electric nasal aspirator (2022), 9 descendants of its own
- K233901: Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA006, NASA008, NASA009) (2024), 3 descendants of its own
- K244033: Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA610) (2025), 2 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K082762
Methodology: https://510kreport.com/methodology