# K982304: Devilbiss Suction Unit

- Pathway: 510(k) (Traditional)
- Applicant: Sunrise Medical Hhg, Inc.
- Decided: Sep 25, 1998 after 86 days
- Product code: JCX (Apparatus, Suction, Ward Use, Portable, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 878.4780
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K935218 (1994). 1 ancestor in all.
26 later devices descend from it; 8 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935218: Schuco-Vac Model 178, Schuco, Inc. (1994) Summary page 1.

## Cited in the summary but kept off the family tree
- K872009: DeVilbiss 7304. 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
- K063448: Emg AC/DC Suction Unit (2006), 16 descendants of its own
- K082762: Aardvark Nasal Irrigation and Aspiration Device (2008), 15 descendants of its own
- 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

## Recalls of this device
- May 23, 2016 · Class II · Z-2246-2016: A small percentage of units of 7305 Series Vacu-Aide Suction Units are experiencing premature failure during operation.
- Mar 7, 2013 · Class II · Z-2319-2013: End users of the DeVilbiss Disposable Suction Container/Filter had exposed the bacterial filter cartridge to fluid, thereby occluding the filter and rendering it unusable.
- Oct 27, 2008 · Not classified · Z-0863-2009: Improper suction: Regulator knob does not turn properly which can affect the suction level.

## Indications for use
The DeVilbiss Suction Unit is used to remove fluids from the airway or respiratory support system and infectious materials from wounds. Configurations of the device will be intended for the home, institutional, and field/transport environments. The device is for use orly on the order of a physcian or other lincensed practitioner (e.g. EMT-field use).

Source page: https://510kreport.com/device/K982304
Methodology: https://510kreport.com/methodology