510(k) · Cleared
ClearedAxiom Multipurpose Wound Drain
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Axiom Medical, Inc. · BSO Catheter, Conduction, Anesthetic
Cleared on May 17, 2000 after a 208-day review. The FDA summary names its predicate without a number. 9 later devices descend from it.
- Decided
- May 17, 2000
- Review
- 208 days
- Class
- Class II
- Product code
- BSO
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 3 citing it directly.
- This deviceK993592 Axiom Multipurpose Wound DrainAxiom Medical, Inc. · 2000
- 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 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · 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) | K993592 | Axiom Multipurpose Wound Drain | Axiom Medical, Inc. | 2000 | — |
| +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 |
| 2011 | 1 | 0 |
| 2013 | 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 BSO? 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 BSO device
- #1 K241410 EDEN ControlCathscore 9.4 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | — | Axiom Sump Drain with Filter Named without a submission number | |
| * | — | Axiom Interpleural Anesthesia Catheter Named without a submission number |
What descends from it? (9)
3 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, K052286 (The Catheter Exchange, Inc., 2005) has gone furthest, with 6 descendants of its own.
How does its category compare?
All BSO devicesBSO Catheter, Conduction, Anesthetic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BSO
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BSO
205in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BSO
2so far in 2026, the most since 2007
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · BSO
139in 2025
MAUDE reports naming product code BSO, 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 | 2 | — | 0 | 18 |
| 2008 | 3 | 155 | 0 | 14 |
| 2009 | 1 | — | 1 | 71 |
| 2010 | 1 | — | 0 | 57 |
| 2011 | 4 | 109 | 0 | 31 |
| 2012 | 0 | — | 0 | 52 |
| 2013 | 1 | — | 0 | 73 |
| 2014 | 2 | — | 0 | 45 |
| 2015 | 1 | — | 0 | 43 |
| 2016 | 5 | 281 | 0 | 71 |
| 2017 | 3 | 205 | 0 | 38 |
| 2018 | 2 | — | 0 | 80 |
| 2019 | 2 | — | 0 | 779 |
| 2020 | 2 | — | 0 | 159 |
| 2021 | 0 | — | 0 | 146 |
| 2022 | 0 | — | 0 | 135 |
| 2023 | 2 | — | 0 | 79 |
| 2024 | 0 | — | 0 | 98 |
| 2025 | 1 | — | 0 | 139 |
| 2026 | 0 | — | 2 (1) | — |
What is it indicated for?
Typical applications include:
For use where a routine drainage tube is required to drain fluids and exudates during surgery or after surgery. The additional lumen allows for sump gravity, irrigation function or application of local anaesthetic to relieve postoperative pain.
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/K993592 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993592: Axiom Multipurpose Wound Drain.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993592
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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