510(k) · Cleared
ClearedAspira Pleural Drainage System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merit Medical Systems, Inc. · DWM Apparatus, Suction, Patient Care
Cleared on Mar 3, 2023 as substantially equivalent to K110409 (C.R. Bard, Inc., 2011) after a 555-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- Mar 3, 2023
- Review
- 555 days
- Class
- Class II
- Product code
- DWM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K971753 (1997). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK971753 Denver Pleurx Pleural Catheter Kit, Catalog NO. 50-7000, Denver…Denver Biomaterials, Inc. · 1997
- 2 generations backK071095 Aspira Pleural Drainage SystemBard Access Systems, Inc. · 2007
- 1 generation backK110409 Aspira Pleural Drainage SystemC.R. Bard, Inc. · 2011 · Recalled
- This deviceK212696 Aspira Pleural Drainage SystemMerit Medical Systems, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K971753 | Denver Pleurx Pleural Catheter Kit, Catalog NO. 50-7000, Denver Pleurx Home… | Denver Biomaterials, Inc. | 1997 | — |
| −2 | K071095 | Aspira Pleural Drainage System | Bard Access Systems, Inc. | 2007 | — |
| −1 | K110409 | Aspira Pleural Drainage System | C.R. Bard, Inc. | 2011 | 1 |
| 0 (this device) | K212696 | Aspira Pleural Drainage System | Merit Medical Systems, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2005 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DWM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DWM device
- #1 K210509 Rocket Platinum Cured Cathterscore 3.2 · 5 generations · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K110409 | Aspira Pleural Drainage SystemSummary page 4…Aspira Pleural Drainage System Classification Name: Apparatus, Suction, Patient Care Predicate Premarket Notification: K110409 Device Manufacturer: Merit Medical Systems, Inc. This predicate has not been subject… | 2011 |
| † | K201155 | PleurX Peritoneal Catheter System | 2020 |
| † | K160450 | Pleurx Pleural Catheter System | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 4 companies; a new generation was cleared every 9.9 years on median.
- 1 of the 7 ancestors has a recall of any class.
- 3 other devices also cite its predicate K110409.
How does its category compare?
All DWM devicesDWM Apparatus, Suction, Patient Care: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · DWM
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · DWM
Too few DWM 510(k)s in any year since 2007 to give a median.
Recalls per year · DWM
2in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DWM
74in 2025
MAUDE reports naming product code DWM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 2 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 8 |
| 2011 | 1 | — | 0 | 23 |
| 2012 | 2 | — | 0 | 16 |
| 2013 | 1 | — | 0 | 78 |
| 2014 | 0 | — | 2 | 94 |
| 2015 | 1 | — | 0 | 82 |
| 2016 | 1 | — | 0 | 49 |
| 2017 | 1 | — | 0 | 62 |
| 2018 | 0 | — | 0 | 51 |
| 2019 | 1 | — | 0 | 57 |
| 2020 | 1 | — | 0 | 68 |
| 2021 | 1 | — | 0 | 143 |
| 2022 | 0 | — | 0 | 62 |
| 2023 | 1 | — | 0 | 108 |
| 2024 | 0 | — | 0 | 70 |
| 2025 | 0 | — | 0 | 74 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Aspira Pleural Drainage System is intended for long-term intermittent drainage of pleural fluid accumulated in the pleural cavity forth purpose of relieving symptoms associated with pleural effusion. • Aspira Drainage Catheter: The Aspira Drainage System is indicated for intermittent drainage of recurrent and symptomatic pleural effusions. The catheter is intended for long-term access of the pleural cavity in order to relieve symptoms such as dyspnea…
Read the full statement (253 words)
The Aspira Pleural Drainage System is intended for long-term intermittent drainage of pleural fluid accumulated in the pleural cavity forth purpose of relieving symptoms associated with pleural effusion.
• Aspira Drainage Catheter: The Aspira Drainage System is indicated for intermittent drainage of recurrent and symptomatic pleural effusions. The catheter is intended for long-term access of the pleural cavity in order to relieve symptoms such as dyspnea and chest discomfort associated with malignant pleural effusions and other recurrent effusions.
• Aspira Drainage Bag: The Aspira Drainage Bag is indicated for use only with the Aspira Valve Assembly for intermittent drainage.
• Aspira Drainage Bottle: The Aspira Drainage Bottle is indicated for use only with the Aspira Valve Assembly for intermittent drainage.
• Aspira Dressing Kit: The Aspira Dressing Kit is indicated for dressing of the drainage catheter and exit site.
• Aspira Valve Assembly / Repair Kit: The Aspira Valve Assembly is indicated for use with silicone catheters with inner diameters between 0.103" - 0.116 such as the Aspira, Asept®, PleurX® and Rocket® catheters.
• Aspira Luer Adapter: The Luer Adapter is intended to provide access to the Aspira Valve Assembly. It is used to drain fluid using standard wall suction, water seal drainage system, glass vacuum bottle, syringe, or other appropriate method.
• Aspira Universal Tubing Adapter: The Universal Tubing Adapter is intended to provide access to the Aspira Valve Assembly. It is used to drain fluid using standard wall suction, water seal drainage system, glass vacuum bottle, syringe, or other appropriate method.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212696 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212696: Aspira Pleural Drainage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212696
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026