# K120065: Plaxtron Suction Unit, Model 88AA51/88AA61 Series

- Pathway: 510(k) (Traditional)
- Applicant: Plaxtron Industrial (M) Sdn. Bhd.
- Decided: Apr 3, 2012 after 85 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: 2 generations back to K935218 (1994). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982304: Devilbiss Suction Unit, Sunrise Medical Hhg, Inc. (1998) Summary page 1.

## Most influential descendants
- K251111: Cary (2025), 0 descendants of its own

## Recalls of this device
- Jan 13, 2026 · Class II · Z-1341-2026: units manufactured in a limited time period may emit electromagnetic noise beyond the acceptable limits for RTCA application specified in RTCA DO-160G Chapter 21, Equipment Category M.
- Dec 18, 2020 · Class II · Z-0868-2021: Component failures may cause the unit to lose all suction. Users will need to obtain alternate suction devices or methods, leading to a delay in treatment and, in worst case scenario, potential suffoc
- Aug 31, 2017 · Class II · Z-0973-2018: A shipment of LCSU 4 suction units and canisters attempted importation into the United States but was refused by FDA for lack of necessary approvals with CDRH by the foreign firms.

## Indications for use
The device is to be used to remove fluids from the airway or respiratory support system. The device creates a negative pressure (vacuum) that draws fluids through disposable tubing that is connected to a collection canister. The fluids are trapped in the collection canister for proper disposal. It is for use only on the order of a physician or other licensed practitioner (e.g. EMT-field use).

Source page: https://510kreport.com/device/K120065
Methodology: https://510kreport.com/methodology