510(k) · Cleared
ClearedPleuraFlow System with FlowGlide
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clearflow, Inc. · OTK Wound Drain Catheter System
Cleared on Nov 30, 2016 as substantially equivalent to K150042 (Clearflow, Inc., 2015) after a 21-day review. Its family tree reaches back 4 generations to 1997. 2 later devices descend from it.
- Decided
- Nov 30, 2016
- Review
- 21 days
- Class
- Class II
- Product code
- OTK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K973703 (1997). 5 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK973703 Jackson-Pratt Hemaduct Wound Drain, Jackson-Pratt Gold Hemaduct…Allegiance Healthcare Corp. · 1997
- 3 generations backK052286 Deutsch Anti-Blockage Wound DrainThe Catheter Exchange, Inc. · 2005
- 2 generations backK093565 Pleuraflow Catheter SystemClear Catheter Systems · 2010
- 1 generation backK150042 PleuraFlow SystemClearflow, Inc. · 2015
- This deviceK163139 PleuraFlow System with FlowGlideClearflow, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK191733 The ZIP Accessory Shuttle for PleuraFlow SystemClearflow, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK182067 PleuraFlow System with FlowGlide Extra Drainage LengthClearflow, Inc. · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K973703 | Jackson-Pratt Hemaduct Wound Drain, Jackson-Pratt Gold Hemaduct Wound Drain | Allegiance Healthcare Corp. | 1997 | — |
| −3 | K052286 | Deutsch Anti-Blockage Wound Drain | The Catheter Exchange, Inc. | 2005 | — |
| −2 | K093565 | Pleuraflow Catheter System | Clear Catheter Systems | 2010 | — |
| −1 | K150042 | PleuraFlow System | Clearflow, Inc. | 2015 | — |
| 0 (this device) | K163139 | PleuraFlow System with FlowGlide | Clearflow, Inc. | 2016 | — |
| +1 | K191733 | The ZIP Accessory Shuttle for PleuraFlow System | Clearflow, Inc. | 2019 | — |
| +1 | K182067 | PleuraFlow System with FlowGlide Extra Drainage Length | Clearflow, Inc. | 2018 | — |
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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K150042 | PleuraFlow SystemSummary page 5…K163139 p 2/4 Product Codes: OTK and GBX Predicate Device: Predicate device is the PleuraFlow Catheter System (K150042) by ClearFlow, Inc. Reference Device: ADAPt Universal Laparoscopic Port K082156. Device Description:… | 2015 |
| † | K082156 | Adapt Universal Laparoscopic Port, Model 405940, 405912, 40591213 | 2008 |
What descends from it? (2)
2 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?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 5.1 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K191733 (Clearflow, Inc., 2019) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K150042.
How does its category compare?
All OTK devicesOTK Wound Drain Catheter System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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® System with FlowGlide™ is indicated for use during cardiothoracic surgical procedures and chest trauma. Its Active Clearance Technology® proactively removes clots formed inside the chest tube to prevent or minimize chest tube occlusion with clot. A patent chest tube enables evacuation of blood and fluid from the operative site after closure of the surgical wound and reduces retained blood. The product is indicated for adult and pediatric patients including infant, preadolescent and adolescent patients under clinical settings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163139 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163139: PleuraFlow System with FlowGlide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163139
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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