Medela Thopaz Model 200 0288
FDA 510(k)Class II (US FDA 510(k))
by Medela LLC
Identifiers
- 510(k) Number
- K080212 FDA 510(k)
- FDA Product Code
- BTA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4780 FDA 510(k)
- Regulation Number
- 878.4780 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Medela Thopaz Model 200 0288 is an AC/DC powered, maintenance-free secretion aspirator for thoracic drainage. It utilizes a DC-motor with membrane aggregate to provide suction with a maximum of -10 kPa / -75 mmHg and a flow rate of 5 L/min.
This device is supplied as a thoracic drainage system and features double lumen tubing that applies suction only when needed, enhancing patient comfort and therapy efficiency. The system enables data recording and transfer to PC for filing with patient records. It is a Class II device cleared by the FDA under product code BTA.
Frequently asked questions
What is the Medela Thopaz Model 200 0288 used for?
The Medela Thopaz Model 200 0288 is a maintenance-free secretion aspirator designed specifically for thoracic drainage. It utilizes a DC-motor with membrane aggregate to provide effective suction for removing fluids from the thoracic cavity.
How is the Medela Thopaz Model 200 0288 supplied?
This device is supplied as a complete thoracic drainage system that includes double lumen tubing. The tubing is designed to apply suction only when needed, which enhances patient comfort and improves therapy efficiency.
What are the technical specifications of the Medela Thopaz Model 200 0288?
The Medela Thopaz Model 200 0288 is an AC/DC powered device that provides suction with a maximum of -10 kPa / -75 mmHg and a flow rate of 5 L/min. It features a DC-motor with membrane aggregate and is designed for data recording and transfer to PC for patient record filing.
Is the Medela Thopaz Model 200 0288 reusable or single-use?
The device is designed for reuse as it is a maintenance-free aspirator system. However, the tubing components that come into direct contact with the patient may need to be replaced according to clinical protocols and manufacturer guidelines.
What is the regulatory status of the Medela Thopaz Model 200 0288?
The Medela Thopaz Model 200 0288 is a Class II device cleared by the FDA under product code BTA. It received FDA 510(k) clearance with K number K080212 on July 23, 2008, and was determined to be substantially equivalent to predicate devices.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: MEDELA THOPAZ, MODEL 200 0288 (K080212) — FDA 510(k) | Innolitics, MEDELA THOPAZ INSTRUCTIONS FOR USE MANUAL Pdf Download, MEDELA THOPAZ MANUAL Pdf Download | ManualsLib, PDF Thopaz - Medela
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K080212 | Class II | Active |
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Manufacturer
- Manufacturer
- Medela LLC
- FDA Applicant
- Medela AG
Sources (1)
- FDA 510(k) K080212 24 fields · synced Sep 22, 2026