Edrain Chest Drainage System
FDA 510(k) K130131 · Atrium Medical Corp.
510(k) numberK130131
Submission
- Device name
- Edrain Chest Drainage System
- Applicant
- Atrium Medical Corp.
Hudson, NH, US - Received
- January 18, 2013
- Decision date
- February 28, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- BTA – Pump, Portable, Aspiration (Manual Or Powered)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4780
- Specialty
- General, Plastic Surgery
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| K251101 | AIRO Suction Unit (AIRO-01)BTA · Traditional | Cro, LLC | 04/26/2025SE |
| K250697 | Electric Nasal Aspirator (BC026, BC025, BC023)BTA · Traditional | Shenzhen Kingboom Technology Co., Ltd. | 04/23/2025SE |
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| K130142 | Flixene Ifg Vascular GraftDSY · Traditional | 03/15/2013SE |
| K122138 | Atrium Flixene Ifg Vascular GraftDSY · Special | 08/17/2012SE |
| K121070 | C-Qur RPM MeshFTL · Special | 04/26/2012SE |
| K113112 | Clearway RX NB CatheterDQY · Special | 11/17/2011SE |
| K110110 | Atrium Centrilfx MeshFTL · Special | 02/15/2011SE |
| K102596 | Atrium Graduated Wall Flixene Ax-Bifem GraftDSY · Special | 10/05/2010SE |
Questions and answers
When was Edrain Chest Drainage System cleared by the FDA?
Edrain Chest Drainage System (K130131) received a 510(k) decision of Substantially Equivalent on February 28, 2013, 41 days after the submission was received.
What is the product code of K130131?
The FDA product code is BTA – Pump, Portable, Aspiration (Manual Or Powered), a Class II (moderate risk) device regulated under 21 CFR 878.4780.