# K080212: Medela Thopaz, Model 200 0288

- Pathway: 510(k) (Traditional)
- Applicant: Medela AG
- Decided: Jul 23, 2008 after 176 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: 3 generations back to K933902 (1994). 5 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061205: Medela Vario 8/18/CI Secretion & Surgical Aspirator, Medela AG (2006) Summary page 1.
- K043544: Medela Dominant 35 C/I Secretion and Surgical Aspirator, Medela AG (2005) Summary page 1.

## Most influential descendants
- K130210: Medela Thopaz (2013), 2 descendants of its own
- K141553: Medela Thopaz+ (2014), 1 descendant of its own
- K103042: Atmos E 201 Thorax and Atmos S 201 Thorax (2011), 1 descendant of its own
- K241799: ATMOS C 051 Thorax (317.0200.0); Secretion canister 800ml (317.1300.0); Hose system (312.1177.0); Hose system with connector small (312.1206.0); Hose system with connector medium (312.1207.0); Hose system with connector large (312.1208.0); Hose system with Y-connector medium (312.1209.0); Hose system with Y-connector large (312.1210.0); Universal bracket for ATMOS C 051 Thorax (316.0200.0); Bracket for ATMOS C 051 Thorax - Standard rail (317.1160.0); Charger Storage for bracket ATMOS C (2025), 0 descendants of its own
- K181667: Thoraguard System (2018), 0 descendants of its own

## Indications for use
The Medela THOPAZ Suction Pump is indicated for aspiration and removal of surgical fluids, tissue, gases, bodily fluids or infectious materials from a patient's respiratory support system (after surgery). Generally the Medela THOPAZ is intended to be used in all situations where chest drains are applied - especially for thoracic drainage and in situations such as pneumothorax, after surgery (post operative), thorax injury, pleura effusion, pleuryempyem or other related conditions.

Source page: https://510kreport.com/device/K080212
Methodology: https://510kreport.com/methodology