510(k) · Cleared
ClearedAspira Pleural Drainage System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bard Access Systems, Inc. · DWM Apparatus, Suction, Patient Care
Cleared on May 18, 2007 as substantially equivalent to K971753 (Denver Biomaterials, Inc., 1997) and 4 other predicates after a 30-day review. Its family tree reaches back 1 generation to 1997. 9 later devices descend from it.
- Decided
- May 18, 2007
- Review
- 30 days
- Class
- Class II
- Product code
- DWM
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 1 generation to K971753 (1997). 5 ancestors in all. 9 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK971753 Denver Pleurx Pleural Catheter Kit, Catalog NO. 50-7000, Denver…Denver Biomaterials, Inc. · 1997
- This deviceK071095 Aspira Pleural Drainage SystemBard Access Systems, Inc. · 2007
- Descendant · cites it directly · 8 of its ownK110409 Aspira Pleural Drainage SystemC.R. Bard, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 6 of its ownK112831 Pleurx Pleural Catheter SystemsCare Fusion · 2012
- Descendant · 3 generations on · 2 of its ownK123033 Rocket Ipc Insertion Pack, Rocket Ipc Mini Insertion Set, Rocket Ipc…Rocket Medical Plc · 2013
- Descendant · 2 generations on · 2 of its ownK121849 Pleurx Pleural Catheter System, Pleurx Catheter Access Kit, Pleurx…Care Fusion · 2012
- Descendant · 3 generations on · 1 of its ownK141965 Pleurx Pleural Catheter System, Pleurx Catheter Access KitCare Fusion · 2015
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K110409Aspira Pleural Drainage SystemC.R. Bard, Inc. · 2011 · cites it directly8descendants
- K112831Pleurx Pleural Catheter SystemsCare Fusion · 2012 · 2 generations on6descendants
- K123033Rocket Ipc Insertion Pack, Rocket Ipc Mini Insertion Set, Rocket Ipc Dressing Pack and…Rocket Medical Plc · 2013 · 3 generations on2descendants
- K121849Pleurx Pleural Catheter System, Pleurx Catheter Access Kit, Pleurx Catheter Insertion…Care Fusion · 2012 · 2 generations on2descendants
- K141965Pleurx Pleural Catheter System, Pleurx Catheter Access KitCare Fusion · 2015 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K971753 | Denver Pleurx Pleural Catheter Kit, Catalog NO. 50-7000, Denver Pleurx Home… | Denver Biomaterials, Inc. | 1997 | — |
| 0 (this device) | K071095 | Aspira Pleural Drainage System | Bard Access Systems, Inc. | 2007 | — |
| +1 | K110409 | Aspira Pleural Drainage System | C.R. Bard, Inc. | 2011 | 1 |
| +2 | K112831 | Pleurx Pleural Catheter Systems | Care Fusion | 2012 | — |
| +3 | K123033 | Rocket Ipc Insertion Pack, Rocket Ipc Mini Insertion Set, Rocket Ipc Dressing… | Rocket Medical Plc | 2013 | — |
| +2 | K121849 | Pleurx Pleural Catheter System, Pleurx Catheter Access Kit, Pleurx Catheter… | Care Fusion | 2012 | — |
| +3 | K141965 | Pleurx Pleural Catheter System, Pleurx Catheter Access Kit | Care Fusion | 2015 | — |
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 |
|---|---|---|
| 2011 | 1 | 0 |
| 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? (5)
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 |
|---|---|---|---|
| * | K971753 | Denver Pleurx Pleural Catheter Kit, Catalog NO. 50-7000, Denver Pleurx Home Drainage…Summary page 1…74 DWM -Patient Care Suction Apparatus Classification Panel: Cardiovascular devices 510(k) Clearance: K971753, concurrence date June 27, 1997. K0 10642, concurrence date March 20, 2001… | 1997 |
| * | K010642 | Pleurx Pleural Catheter and Drainage KitsSummary page 1…Classification Panel: Cardiovascular devices 510(k) Clearance: K971753, concurrence date June 27, 1997. K0 10642, concurrence date March 20, 2001 K01 183 1, concurrence date June 28, 2001… | 2001 |
| * | K011831 | Modification to Pleurx Pleural Catheter and Drainage KitsSummary page 1…K971753, concurrence date June 27, 1997. K0 10642, concurrence date March 20, 2001 K01 183 1, concurrence date June 28, 2001 K051084, concurrence date June 13, 2005… | 2001 |
| * | K051084 | Denver Pleurx Drainage Kit and Denver Pleurx Vacuum Bottle with Drainage LineSummary page 1…K0 10642, concurrence date March 20, 2001 K01 183 1, concurrence date June 28, 2001 K051084, concurrence date June 13, 2005 K052436, concurrence date October 6, 2005… | 2005 |
| * | K052436 | Pleurx Pleural Catheter Kit, Model 50-7000Summary page 1…K01 183 1, concurrence date June 28, 2001 K051084, concurrence date June 13, 2005 K052436, concurrence date October 6, 2005 000… | 2005 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110409 | Aspira Pleural Drainage System | 2011 | 8 |
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?
- None of the 5 ancestors has a recall.
- Of its descendants, K110409 (C.R. Bard, Inc., 2011) has gone furthest, with 8 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. 2007, 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 AspiraTM 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 AspiraTM Drainage Bag is indicated for use only with the AspiraTM Drainage Catheter for intermittent drainage. The…
Read the full statement (138 words)
The AspiraTM 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 AspiraTM Drainage Bag is indicated for use only with the AspiraTM Drainage Catheter for intermittent drainage.
The AspiraTM Dressing Kit is indicated for dressing of a catheter and exit site.
The Aspira TM Luer Adapter is intended to provide access to the AspiraTM Drainage Catheter. It is used to drain fluid using standard wall suction, syringe or other appropriate method.
The AspiraTM Valve Assembly attaches to the Aspira TM Drainage Catheter. The AspiraTM Repair Kit is for the repair of the AspiraTM Drainage Catheter and replacement of the AspiraTm Valve.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071095 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071095: Aspira Pleural Drainage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071095
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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