510(k) · Cleared
ClearedPleuraflow Catheter System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clear Catheter Systems · OTK Wound Drain Catheter System
Cleared on Dec 3, 2010 as substantially equivalent to K052286 (The Catheter Exchange, Inc., 2005) after a 380-day review. Its family tree reaches back 2 generations to 1997. 5 later devices descend from it.
- Decided
- Dec 3, 2010
- Review
- 380 days
- Class
- Class II
- Product code
- OTK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K973703 (1997). 3 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK973703 Jackson-Pratt Hemaduct Wound Drain, Jackson-Pratt Gold Hemaduct…Allegiance Healthcare Corp. · 1997
- 1 generation backK052286 Deutsch Anti-Blockage Wound DrainThe Catheter Exchange, Inc. · 2005
- This deviceK093565 Pleuraflow Catheter SystemClear Catheter Systems · 2010
- Descendant · cites it directly · 4 of its ownK150042 PleuraFlow SystemClearflow, Inc. · 2015
- Descendant · 2 generations on · 2 of its ownK163139 PleuraFlow System with FlowGlideClearflow, Inc. · 2016
- Descendant · 3 generations on · 0 of its ownK191733 The ZIP Accessory Shuttle for PleuraFlow SystemClearflow, Inc. · 2019
- Descendant · 3 generations on · 0 of its ownK182067 PleuraFlow System with FlowGlide Extra Drainage LengthClearflow, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK153681 PleuraFlow SystemClearflow, Inc. · 2016
Most influential descendants
Showing 5 of 5 · See all- K150042PleuraFlow SystemClearflow, Inc. · 2015 · cites it directly4descendants
- K163139PleuraFlow System with FlowGlideClearflow, Inc. · 2016 · 2 generations on2descendants
- K191733The ZIP Accessory Shuttle for PleuraFlow SystemClearflow, Inc. · 2019 · 3 generations on0descendants
- K182067PleuraFlow System with FlowGlide Extra Drainage LengthClearflow, Inc. · 2018 · 3 generations on0descendants
- K153681PleuraFlow SystemClearflow, Inc. · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K973703 | Jackson-Pratt Hemaduct Wound Drain, Jackson-Pratt Gold Hemaduct Wound Drain | Allegiance Healthcare Corp. | 1997 | — |
| −1 | K052286 | Deutsch Anti-Blockage Wound Drain | The Catheter Exchange, Inc. | 2005 | — |
| 0 (this device) | K093565 | Pleuraflow Catheter System | Clear Catheter Systems | 2010 | — |
| +1 | K150042 | PleuraFlow System | Clearflow, Inc. | 2015 | — |
| +2 | K163139 | PleuraFlow System with FlowGlide | Clearflow, Inc. | 2016 | — |
| +3 | K191733 | The ZIP Accessory Shuttle for PleuraFlow System | Clearflow, Inc. | 2019 | — |
| +3 | K182067 | PleuraFlow System with FlowGlide Extra Drainage Length | Clearflow, Inc. | 2018 | — |
| +2 | K153681 | PleuraFlow System | Clearflow, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 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 OTK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K052286 | Deutsch Anti-Blockage Wound DrainSummary page 1…ce(s): The primary predicate device used to demonstrate substantial equivalence is the Deutsch Anti-Blockage Wound Drain (K052286). Device Description: The PleuraFlow Catheter System is comprised of a silicone drainage tube and a sh… | 2005 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150042 | PleuraFlow System | 2015 | 4 |
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 13 years and passes through 3 companies; a new generation was cleared every 7.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K150042 (Clearflow, Inc., 2015) has gone furthest, with 4 descendants of its own.
How does its category compare?
All OTK devicesOTK Wound Drain Catheter System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · OTK
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · OTK
Too few OTK 510(k)s in any year since 2007 to give a median.
Recalls per year · OTK
No recall names OTK since 2007.
Adverse event reports per year · OTK
1in 2023
MAUDE reports naming product code OTK, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 3 |
| 2016 | 2 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 9 |
| 2021 | 1 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The PleuraFlow Catheter is indicated for use as an adjunctive device during open Surgical procedures in order to prevent fluid accumulation within the operative site after closure of the surgical wound. The device is indicated for use in thoracic surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093565 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093565: Pleuraflow Catheter System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093565
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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