510(k) · Cleared
ClearedPleurx Pleural Catheter and Drainage Kits
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 Mar 20, 2001 after a 15-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 15 later devices descend from it.
- Decided
- Mar 20, 2001
- Review
- 15 days
- Class
- Class II
- Product code
- DWM
- Recalls
- None
- Predicates
- 0
15 later devices descend from it, 2 citing it directly.
- This deviceK010642 Pleurx Pleural Catheter and Drainage KitsDenver Biomedicals, Inc. · 2001
- 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 · 3 generations on · 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 · 3 generations on6descendants
- 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) | K010642 | Pleurx Pleural Catheter and Drainage Kits | Denver Biomedicals, Inc. | 2001 | — |
| +1 | K071095 | Aspira Pleural Drainage System | Bard Access Systems, Inc. | 2007 | — |
| +2 | K110409 | Aspira Pleural Drainage System | C.R. Bard, Inc. | 2011 | 1 |
| +3 | 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), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (15)
See all 152 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 | — |
https://510kreport.com/device/K010642 · printed Nov 6, 2026
Cite this page
510(k) Report. “K010642: Pleurx Pleural Catheter and Drainage Kits.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010642
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026