510(k) · Cleared
Recalled · Class II · 2022Aspira Pleural Drainage System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · DWM Apparatus, Suction, Patient Care
Cleared on May 11, 2011 as substantially equivalent to K071095 (Bard Access Systems, Inc., 2007) after an 86-day review. Its family tree reaches back 2 generations to 1997. 8 later devices descend from it. It has been recalled once.
- Decided
- May 11, 2011
- Review
- 86 days
- Class
- Class II
- Product code
- DWM
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K971753 (1997). 6 ancestors in all. 8 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK971753 Denver Pleurx Pleural Catheter Kit, Catalog NO. 50-7000, Denver…Denver Biomaterials, Inc. · 1997
- 1 generation backK071095 Aspira Pleural Drainage SystemBard Access Systems, Inc. · 2007
- This deviceK110409 Aspira Pleural Drainage SystemC.R. Bard, Inc. · 2011
- Descendant · cites it directly · 6 of its ownK112831 Pleurx Pleural Catheter SystemsCare Fusion · 2012
- Descendant · 2 generations on · 2 of its ownK123033 Rocket Ipc Insertion Pack, Rocket Ipc Mini Insertion Set, Rocket Ipc…Rocket Medical Plc · 2013
- Descendant · cites it directly · 2 of its ownK121849 Pleurx Pleural Catheter System, Pleurx Catheter Access Kit, Pleurx…Care Fusion · 2012
- Descendant · 2 generations on · 1 of its ownK141965 Pleurx Pleural Catheter System, Pleurx Catheter Access KitCare Fusion · 2015
- Descendant · cites it directly · 0 of its ownK212696 Aspira Pleural Drainage SystemMerit Medical Systems, Inc. · 2023
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K112831Pleurx Pleural Catheter SystemsCare Fusion · 2012 · cites it directly6descendants
- K123033Rocket Ipc Insertion Pack, Rocket Ipc Mini Insertion Set, Rocket Ipc Dressing Pack and…Rocket Medical Plc · 2013 · 2 generations on2descendants
- K121849Pleurx Pleural Catheter System, Pleurx Catheter Access Kit, Pleurx Catheter Insertion…Care Fusion · 2012 · cites it directly2descendants
- K141965Pleurx Pleural Catheter System, Pleurx Catheter Access KitCare Fusion · 2015 · 2 generations on1descendant
- K212696Aspira Pleural Drainage SystemMerit Medical Systems, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K971753 | Denver Pleurx Pleural Catheter Kit, Catalog NO. 50-7000, Denver Pleurx Home… | Denver Biomaterials, Inc. | 1997 | — |
| −1 | K071095 | Aspira Pleural Drainage System | Bard Access Systems, Inc. | 2007 | — |
| 0 (this device) | K110409 | Aspira Pleural Drainage System | C.R. Bard, Inc. | 2011 | — |
| +1 | K112831 | Pleurx Pleural Catheter Systems | Care Fusion | 2012 | — |
| +2 | K123033 | Rocket Ipc Insertion Pack, Rocket Ipc Mini Insertion Set, Rocket Ipc Dressing… | Rocket Medical Plc | 2013 | — |
| +1 | K121849 | Pleurx Pleural Catheter System, Pleurx Catheter Access Kit, Pleurx Catheter… | Care Fusion | 2012 | — |
| +2 | K141965 | Pleurx Pleural Catheter System, Pleurx Catheter Access Kit | Care Fusion | 2015 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 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 K212696 Aspira Pleural Drainage Systemscore 5.5 · 3 generations · no Class I recall
- #2 Held for the reportin the report
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 |
|---|---|---|---|
| * | K071095 | Aspira Pleural Drainage SystemSummary page 1…21 CFR 870.5050 - Class 11 DWM - Patient care suction apparatus Premarket Notification: K071 095, concurrence date 18 May 2007 Manufacturer: Bard Access Systems, Inc. Device The Asp… | 2007 |
What descends from it? (8)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 25, 2022 | Class II | Z-1599-2022 | Environmental control | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 9.9 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K112831 (Care Fusion, 2012) has gone furthest, with 6 descendants of its own.
How does its category compare?
All DWM devicesDWM Apparatus, Suction, Patient Care: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 indicated for intermittent drainage of recurrent and symptomatic pleural effusions. The catheter is intended for long-term access to the pleural cavity in order to relieve symptoms such as dyspnea and chest discomfort associated with malignant pleural effusion and other recurrent effusions. The Aspira® Drainage Bag is indicated for use only with the Aspira® Drainage Catheter for intermittent drainage. The Aspira®…
Read the full statement (144 words)
The Aspira® Pleural Drainage System is indicated for intermittent drainage of recurrent and symptomatic pleural effusions. The catheter is intended for long-term access to the pleural cavity in order to relieve symptoms such as dyspnea and chest discomfort associated with malignant pleural effusion and other recurrent effusions.
The Aspira® Drainage Bag is indicated for use only with the Aspira® Drainage Catheter for intermittent drainage.
The Aspira® Dressing Kit is indicated for dressing of a catheter and exit site.
The Aspira® Luer/Universal Adapter is intended to provide access to the Aspira® Drainage Catheter. It is used to drain fluid using standard wall suction, water seal drainage system, glass vacuum bottle, syringe or other appropriate method.
The Aspira® Valve Assembly attaches to the Aspira® Drainage Catheter. The Aspira® Repair Kit is for the repair of the Aspira® Drainage Catheter and replacement of the Aspira® Valve Assembly.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110409 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110409: 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/K110409
Report an extraction error
Are you the manufacturer?
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