510(k) · Cleared
ClearedDeutsch Anti-Blockage Wound Drain
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Catheter Exchange, Inc. · GBX Catheter, Irrigation
Cleared on Oct 21, 2005 as substantially equivalent to K973703 (Allegiance Healthcare Corp., 1997) and 1 other predicate after a 60-day review. Its family tree reaches back 1 generation to 1997. 6 later devices descend from it.
- Decided
- Oct 21, 2005
- Review
- 60 days
- Class
- Class I
- Product code
- GBX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K973703 (1997). 2 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK973703 Jackson-Pratt Hemaduct Wound Drain, Jackson-Pratt Gold Hemaduct…Allegiance Healthcare Corp. · 1997
- This deviceK052286 Deutsch Anti-Blockage Wound DrainThe Catheter Exchange, Inc. · 2005
- Descendant · cites it directly · 5 of its ownK093565 Pleuraflow Catheter SystemClear Catheter Systems · 2010
- Descendant · 2 generations on · 4 of its ownK150042 PleuraFlow SystemClearflow, Inc. · 2015
- Descendant · 3 generations on · 2 of its ownK163139 PleuraFlow System with FlowGlideClearflow, Inc. · 2016
- Descendant · 4 generations on · 0 of its ownK191733 The ZIP Accessory Shuttle for PleuraFlow SystemClearflow, Inc. · 2019
- Descendant · 4 generations on · 0 of its ownK182067 PleuraFlow System with FlowGlide Extra Drainage LengthClearflow, Inc. · 2018
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K093565Pleuraflow Catheter SystemClear Catheter Systems · 2010 · cites it directly5descendants
- K150042PleuraFlow SystemClearflow, Inc. · 2015 · 2 generations on4descendants
- K163139PleuraFlow System with FlowGlideClearflow, Inc. · 2016 · 3 generations on2descendants
- K191733The ZIP Accessory Shuttle for PleuraFlow SystemClearflow, Inc. · 2019 · 4 generations on0descendants
- K182067PleuraFlow System with FlowGlide Extra Drainage LengthClearflow, Inc. · 2018 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K973703 | Jackson-Pratt Hemaduct Wound Drain, Jackson-Pratt Gold Hemaduct Wound Drain | Allegiance Healthcare Corp. | 1997 | — |
| 0 (this device) | K052286 | Deutsch Anti-Blockage Wound Drain | The Catheter Exchange, Inc. | 2005 | — |
| +1 | K093565 | Pleuraflow Catheter System | Clear Catheter Systems | 2010 | — |
| +2 | K150042 | PleuraFlow System | Clearflow, Inc. | 2015 | — |
| +3 | K163139 | PleuraFlow System with FlowGlide | Clearflow, Inc. | 2016 | — |
| +4 | K191733 | The ZIP Accessory Shuttle for PleuraFlow System | Clearflow, Inc. | 2019 | — |
| +4 | 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 |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K973703 | Jackson-Pratt Hemaduct Wound Drain, Jackson-Pratt Gold Hemaduct Wound DrainSummary page 1…Catheter, Irrigation The legally marketed device to Jackson-Pratt Wound Drains. The clearance num1trber which we are claiming K973 703 equivalence: Axiom Multipurpose Wound lDrain. The clearance… | 1997 |
| * | K993592 | Axiom Multipurpose Wound DrainSummary page 1…aiming K973 703 equivalence: Axiom Multipurpose Wound lDrain. The clearance number K993592 DEVICE DESCRIPTION The wound drain catheter comprises a proximal drain segment. an internal tubular mnesh assembled with a Iluer… | 2000 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093565 | Pleuraflow Catheter System | 2010 | 5 |
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K093565 (Clear Catheter Systems, 2010) has gone furthest, with 5 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?
The anti-clog drain 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 inserted through the skin adjacent to open surgical incision. The distal end of the drain is positioned within the operative site prior to repair of the incision. The device's proximal end is attached to an appropriate suction source in order to…
Read the full statement (116 words)
The anti-clog drain 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 inserted through the skin adjacent to open surgical incision. The distal end of the drain is positioned within the operative site prior to repair of the incision. The device's proximal end is attached to an appropriate suction source in order to allow efflux of bloody, rosanguinous, chylous, purulent fluid, intestinal, and/or other fluids from the operative site that could impair surgical wound healing. The device is indicated for use in abdominal, thoracic, head and neck, gynecological, urological, spinal, and orthopedic surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052286 · printed Nov 4, 2026
Cite this page
510(k) Report. “K052286: Deutsch Anti-Blockage 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/K052286
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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