# K141553: Medela Thopaz+

- Pathway: 510(k) (Special)
- Applicant: Medela AG
- Decided: Aug 25, 2014 after 75 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: 5 generations back to K933902 (1994). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 10 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130210: Medela Thopaz, Medela AG (2013) Summary page 4.

## Most influential descendants
- K181667: Thoraguard System (2018), 0 descendants of its own

## Indications for use
Thopaz+ is intended to be used for aspiration and removal of surgical fluids, tissue, gases, bodily fluids or infectious materials. Thopaz+ 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. Thopaz+ is intended for use on patients in appropriate care settings.

Source page: https://510kreport.com/device/K141553
Methodology: https://510kreport.com/methodology