Aspira Pleural Drainage System
FDA 510(k) K212696 · Merit Medical Systems, Inc.
510(k) numberK212696
Submission
- Device name
- Aspira Pleural Drainage System
- Applicant
- Merit Medical Systems, Inc.
South Jordan, UT, US - Received
- August 25, 2021
- Decision date
- March 3, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DWM – Apparatus, Suction, Patient Care
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5050
- Specialty
- Cardiovascular
Other 510(k)s with product code DWM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K210509 | Rocket Platinum Cured CathterDWM · Traditional | Rocket Medical Plc | 09/09/2021SESK |
| K201404 | Passio Pump Drainage SystemDWM · Traditional | Bearpac Medical | 11/20/2020SE |
| K190292 | Passio Pump Drainage SystemDWM · Traditional | Bearpac Medical | 07/25/2019SE |
| K163321 | Rocket Indwelling Pleural Catheter (IPC) Insertion KitDWM · Traditional | Rocket Medical Plc | 08/17/2017SE |
| K160450 | Pleurx Pleural Catheter SystemDWM · Traditional | Care Fusion | 10/31/2016SE |
| K141965 | Pleurx Pleural Catheter System, Pleurx Catheter Access KitDWM · Traditional | Care Fusion | 07/02/2015SE |
| K123033 | Rocket Ipc Insertion Pack, Rocket Ipc Mini Insertion Set, Rocket Ipc Dressing Pack and…DWM · Traditional | Rocket Medical Plc | 02/01/2013SE |
| K121849 | Pleurx Pleural Catheter System, Pleurx Catheter Access Kit, Pleurx Catheter Insertion…DWM · Traditional | Care Fusion | 10/18/2012SE |
| K112831 | Pleurx Pleural Catheter SystemsDWM · Traditional | Care Fusion | 02/16/2012SE |
| K110409 | Aspira Pleural Drainage SystemDWM · Special | C.R. Bard, Inc. | 05/11/2011SE |
More from C.R. Bard, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K261310 | FlexTract Deflectable-Rotational Dilator Sheath SetDRE · Traditional | 07/27/2026SE |
| K262086 | PreludeSYNC Radial Compression DeviceDXC · Special | 07/22/2026SE |
| K254073 | StatSeal DiscFRO · Traditional | 05/13/2026SE |
| K251802 | STAR RF Ablation SystemGXI · Traditional | 02/13/2026SE |
| K252892 | SCOUT MD Surgical Guidance SystemNEU · Traditional | 12/19/2025SE |
| K250853 | Merit SyringeFMF · Special | 11/04/2025SE |
| K251265 | Resilience Fully Covered Esophageal Stent SystemESW · Traditional | 07/23/2025SE |
| K250909 | Prelude Wave Hydrophilic Sheath IntroducerDYB · Special | 04/25/2025SE |
| K242873 | Ventrax Delivery SystemDQY · Special | 01/15/2025SE |
| K242229 | Micro Ace Gold Advanced Micro Access SystemDRE · Traditional | 01/15/2025SE |
Questions and answers
When was Aspira Pleural Drainage System cleared by the FDA?
Aspira Pleural Drainage System (K212696) received a 510(k) decision of Substantially Equivalent on March 3, 2023, 555 days after the submission was received.
What is the product code of K212696?
The FDA product code is DWM – Apparatus, Suction, Patient Care, a Class II (moderate risk) device regulated under 21 CFR 870.5050.