# K181667: Thoraguard System

- Pathway: 510(k) (Traditional)
- Applicant: Centese, Inc.
- Decided: Nov 29, 2018 after 157 days
- Product code: BTA (Pump, Portable, Aspiration (Manual Or 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: 6 generations back to K933902 (1994). 9 ancestors in all.
No later device cites it as a predicate yet.
1 of 10 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141553: Medela Thopaz+, Medela AG (2014) Summary page 4.

## Indications for use
The Thoraguard System is intended to be used for aspiration and removal of surgical fluids, tissue, gases, bodily fluids or infectious materials. The Thoraguard System is indicated for all situations where chest drains are applied – especially for thoracic drainage in the pleural and mediastinal cavity in situations such as pneumothorax, after cardiac or thoracic surgery (post-operative), thorax injury, pleural effusion, pleural empyema or other related conditions. The Thoraguard System is intended for use on patients in appropriate care settings.

Source page: https://510kreport.com/device/K181667
Methodology: https://510kreport.com/methodology