# K133196: Impact Model 323 Aspirator

- Pathway: 510(k) (Traditional)
- Applicant: Impact Instrumentation, Inc.
- Decided: Mar 10, 2014 after 144 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: 2 generations back to K935218 (1994). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061133: Simex Suction Pump, Models AC20, AC20K, AC30, DC20, DC30 and DC30S, Novaspine, LLC (2006) Summary page 1.
- K982304: Devilbiss Suction Unit, Sunrise Medical Hhg, Inc. (1998) Summary page 1.

## Indications for use
The IMPACT® Model 323 Aspirator is a self-contained suction apparatus designed for use in removing debris from a patient's airway or respiratory system, secretions, blood, vomitus, surgical fluids, tissue (including bone), bodily fluids and infectious materials from wounds, either during surgery or at the patient's bedside. It is suitable for use in pre-hospital, hospital, mass casualty and transport environments. The Model 323 is only for use by or on the order of a physician.

Source page: https://510kreport.com/device/K133196
Methodology: https://510kreport.com/methodology