# K130210: Medela Thopaz

- Pathway: 510(k) (Traditional)
- Applicant: Medela AG
- Decided: Mar 15, 2013 after 45 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: 4 generations back to K933902 (1994). 7 ancestors in all.
2 later devices descend 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)
- K080212: Medela Thopaz, Model 200 0288, Medela AG (2008) Summary page 1.
- K043140: Express and Oasis Chest Drain, Atrium Medical Corp. (2004) Summary page 1.

## Most influential descendants
- K141553: Medela Thopaz+ (2014), 1 descendant of its own
- K181667: Thoraguard System (2018), 0 descendants of its own

## Indications for use
The Medela® THOPAZ Suction Pump is intended to be used for aspiration and removal of surgical fluids, tissue, gases, bodily fluids or infectious materials. The Medela® THOPAZ Suction Pump 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 Medela® THOPAZ Suction Pump is intended for use on patients in appropriate care settings.

Source page: https://510kreport.com/device/K130210
Methodology: https://510kreport.com/methodology