510(k) · Cleared
ClearedDenver Pleurx Drainage Kit and Denver Pleurx Vacuum Bottle with Drainage Line
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Denver Biomedicals, Inc. · DWM Apparatus, Suction, Patient Care
Cleared on Jun 13, 2005 after a 46-day review. The FDA summary names its predicate without a number. 15 later devices descend from it.
- Decided
- Jun 13, 2005
- Review
- 46 days
- Class
- Class II
- Product code
- DWM
- Recalls
- None
- Predicates
- 0
15 later devices descend from it, 3 citing it directly.
- This deviceK051084 Denver Pleurx Drainage Kit and Denver Pleurx Vacuum Bottle with…Denver Biomedicals, Inc. · 2005
- Descendant · cites it directly · 9 of its ownK071095 Aspira Pleural Drainage SystemBard Access Systems, Inc. · 2007
- Descendant · 2 generations on · 8 of its ownK110409 Aspira Pleural Drainage SystemC.R. Bard, Inc. · 2011 · Recalled
- Descendant · cites it directly · 6 of its ownK112831 Pleurx Pleural Catheter SystemsCare Fusion · 2012
- Descendant · cites it directly · 4 of its ownK093307 Asept Pleural Drainage SystemPfm Medical, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 3 of its ownK093796 Asept Peritoneal Drainage SystemPfm Medical, Inc. · 2010 · Recalled
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K071095Aspira Pleural Drainage SystemBard Access Systems, Inc. · 2007 · cites it directly9descendants
- K110409Aspira Pleural Drainage SystemC.R. Bard, Inc. · 2011 · 2 generations on8descendants
- K112831Pleurx Pleural Catheter SystemsCare Fusion · 2012 · cites it directly6descendants
- K093307Asept Pleural Drainage SystemPfm Medical, Inc. · 2009 · cites it directly4descendants
- K093796Asept Peritoneal Drainage SystemPfm Medical, Inc. · 2010 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K051084 | Denver Pleurx Drainage Kit and Denver Pleurx Vacuum Bottle with Drainage Line | Denver Biomedicals, Inc. | 2005 | — |
| +1 | K071095 | Aspira Pleural Drainage System | Bard Access Systems, Inc. | 2007 | — |
| +2 | K110409 | Aspira Pleural Drainage System | C.R. Bard, Inc. | 2011 | 1 |
| +1 | K112831 | Pleurx Pleural Catheter Systems | Care Fusion | 2012 | — |
| +1 | K093307 | Asept Pleural Drainage System | Pfm Medical, Inc. | 2009 | 2 |
| +2 | K093796 | Asept Peritoneal Drainage System | Pfm Medical, Inc. | 2010 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | — | Denver Pleurx Drainage Kit Named without a submission number |
What descends from it? (15)
See all 153 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K071095 (Bard Access Systems, Inc., 2007) has gone furthest, with 9 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.
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 Denver Pleurx Catheter Kit and the Denver Pleurx Drainage Kit/Vacuum Bottle are indicated for intermittent long term drainage of symptomatic, recurrent pleural effusion, including malignant pleural effusion and other recurrent effusions that do not respond to medical management of the underlying disease. The devices are indicated for 1) the palliation of dyspnea due to pleural effusion and 2) providing pleurodesis (resolution of the pleural effusion).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051084 · printed Nov 5, 2026
Cite this page
510(k) Report. “K051084: Denver Pleurx Drainage Kit and Denver Pleurx Vacuum Bottle with Drainage Line.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K051084
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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