510(k) · Cleared
ClearedJackson-Pratt Hemaduct Wound Drain, Jackson-Pratt Gold Hemaduct Wound Drain
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Allegiance Healthcare Corp. · GBX Catheter, Irrigation
Cleared on Dec 4, 1997 after a 69-day review. The FDA summary names its predicate without a number. 7 later devices descend from it.
- Decided
- Dec 4, 1997
- Review
- 69 days
- Class
- Class I
- Product code
- GBX
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 1 citing it directly.
- This deviceK973703 Jackson-Pratt Hemaduct Wound Drain, Jackson-Pratt Gold Hemaduct…Allegiance Healthcare Corp. · 1997
- Descendant · cites it directly · 6 of its ownK052286 Deutsch Anti-Blockage Wound DrainThe Catheter Exchange, Inc. · 2005
- Descendant · 2 generations on · 5 of its ownK093565 Pleuraflow Catheter SystemClear Catheter Systems · 2010
- Descendant · 3 generations on · 4 of its ownK150042 PleuraFlow SystemClearflow, Inc. · 2015
- Descendant · 4 generations on · 2 of its ownK163139 PleuraFlow System with FlowGlideClearflow, Inc. · 2016
- Descendant · 5 generations on · 0 of its ownK191733 The ZIP Accessory Shuttle for PleuraFlow SystemClearflow, Inc. · 2019
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K052286Deutsch Anti-Blockage Wound DrainThe Catheter Exchange, Inc. · 2005 · cites it directly6descendants
- K093565Pleuraflow Catheter SystemClear Catheter Systems · 2010 · 2 generations on5descendants
- K150042PleuraFlow SystemClearflow, Inc. · 2015 · 3 generations on4descendants
- K163139PleuraFlow System with FlowGlideClearflow, Inc. · 2016 · 4 generations on2descendants
- K191733The ZIP Accessory Shuttle for PleuraFlow SystemClearflow, Inc. · 2019 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 | — |
| +2 | K093565 | Pleuraflow Catheter System | Clear Catheter Systems | 2010 | — |
| +3 | K150042 | PleuraFlow System | Clearflow, Inc. | 2015 | — |
| +4 | K163139 | PleuraFlow System with FlowGlide | Clearflow, Inc. | 2016 | — |
| +5 | K191733 | The ZIP Accessory Shuttle for PleuraFlow System | Clearflow, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2010 | 1 | 0 |
| 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 GBX? 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? (3)
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 |
|---|---|---|---|
| * | — | Jackson-Pratt® Wound Drains Named without a submission number | |
| * | — | Johnson & Johnson Blake™ Drain Named without a submission number | |
| * | — | Zimmer Quad-Lumen™ Drain Named without a submission number |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052286 | Deutsch Anti-Blockage Wound Drain | 2005 | 6 |
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, K052286 (The Catheter Exchange, Inc., 2005) has gone furthest, with 6 descendants of its own.
How does its category compare?
All GBX devicesGBX Catheter, Irrigation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GBX
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · GBX
Too few GBX 510(k)s in any year since 2007 to give a median.
Recalls per year · GBX
6in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GBX
1,179in 2025
MAUDE reports naming product code GBX, 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 | 11 |
| 2008 | 1 | — | 0 | 16 |
| 2009 | 0 | — | 0 | 24 |
| 2010 | 0 | — | 1 | 35 |
| 2011 | 0 | — | 0 | 41 |
| 2012 | 0 | — | 0 | 46 |
| 2013 | 0 | — | 0 | 49 |
| 2014 | 1 | — | 0 | 51 |
| 2015 | 0 | — | 0 | 58 |
| 2016 | 0 | — | 0 | 86 |
| 2017 | 0 | — | 1 | 176 |
| 2018 | 0 | — | 0 | 277 |
| 2019 | 0 | — | 0 | 196 |
| 2020 | 0 | — | 0 | 198 |
| 2021 | 0 | — | 1 | 383 |
| 2022 | 0 | — | 29 | 477 |
| 2023 | 0 | — | 0 | 628 |
| 2024 | 0 | — | 0 | 945 |
| 2025 | 0 | — | 6 | 1,179 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
These wound drains are flexible, multilumen tubes, intended to be used to drain fluids (exudate) from body cavities.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973703 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973703: Jackson-Pratt Hemaduct Wound Drain, Jackson-Pratt Gold Hemaduct Wound Drain.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973703
Report an extraction error
Are you the manufacturer?
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