510(k) · Cleared
ClearedMedcomp Schon XL Soft-Line Double Lumen Catheter, 15CM SBF146, Medcomp Schon XL Soft-Line Double Lumen Catheter, 20CM SB
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Components, Inc. · MPB Catheter, Hemodialysis, Non-Implanted
Cleared on Apr 15, 1999 after a 519-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 of the 25 devices in its family, counting itself, have a Class I recall. 24 later devices descend from it.
- Decided
- Apr 15, 1999
- Review
- 519 days
- Class
- Class II
- Product code
- MPB
- Recalls
- None
- Predicates
- 0
24 later devices descend from it, 4 citing it directly. 2 of the 25 devices in this family, counting this one, have a Class I recall.
- This deviceK974236 Medcomp Schon XL Soft-Line Double Lumen Catheter, 15CM SBF146…Medical Components, Inc. · 1999
- Descendant · cites it directly · 16 of its ownK991320 Medcomp Duo-Flow II Catheter with Lubricious HeparinMedical Components, Inc. · 1999
- Descendant · 2 generations on · 7 of its ownK060509 Palindrome Emerald 14.5 FR Chronic Hemodialysis Catheter with…Tyco Healthcare Group · 2006 · Recalled
- Descendant · 3 generations on · 6 of its ownK062671 14.5 FR Chronic Hemodialysis Catheter with Heparin Coating and…Kendall · 2006 · Recalled
- Descendant · 2 generations on · 6 of its ownK023914 Coaxia Flocontrol CatheterCoaxia, Inc. · 2003
- Descendant · 3 generations on · 5 of its ownK112477 Palindrome H, SI, Hsi Chronic CatheterCovidien · 2011 · Recalled (Class I)
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 24 · See all- K991320Medcomp Duo-Flow II Catheter with Lubricious HeparinMedical Components, Inc. · 1999 · cites it directly16descendants
- K060509Palindrome Emerald 14.5 FR Chronic Hemodialysis Catheter with Heparin CoatingTyco Healthcare Group · 2006 · 2 generations on7descendants
- K06267114.5 FR Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve…Kendall · 2006 · 3 generations on6descendants
- K023914Coaxia Flocontrol CatheterCoaxia, Inc. · 2003 · 2 generations on6descendants
- K112477Palindrome H, SI, Hsi Chronic CatheterCovidien · 2011 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974236 | Medcomp Schon XL Soft-Line Double Lumen Catheter, 15CM SBF146, Medcomp Schon… | Medical Components, Inc. | 1999 | — |
| +1 | K991320 | Medcomp Duo-Flow II Catheter with Lubricious Heparin | Medical Components, Inc. | 1999 | — |
| +2 | K060509 | Palindrome Emerald 14.5 FR Chronic Hemodialysis Catheter with Heparin Coating | Tyco Healthcare Group | 2006 | 4 |
| +3 | K062671 | 14.5 FR Chronic Hemodialysis Catheter with Heparin Coating and Silver… | Kendall | 2006 | 24 |
| +2 | K023914 | Coaxia Flocontrol Catheter | Coaxia, Inc. | 2003 | — |
| +3 | K112477 | Palindrome H, SI, Hsi Chronic Catheter | Covidien | 2011 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 1 |
| 2013 | 1 | 1 |
| 2014 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
2 devices in this family have a Class I recall. 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 MPB device
- #1 K250836 14F Duo-Flow® Side X Side Double Lumen Catheterscore 10.1 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (24)
See all 244 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K112477Palindrome H, SI, Hsi Chronic CatheterCovidien · 2011 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 13 Class I recalls
- K123196Palindrome Precision H Chronic Catheter, Palindrome Precision SI Chronic Catheter, Palindrome Precision Hsi…Covidien · 2013 · 4 generations on · ◆ in the 2013 descendants bar of FIG. 14 Class I recalls
What does this lineage say?
- Of its descendants, K991320 (Medical Components, Inc., 1999) has gone furthest, with 16 descendants of its own.
How does its category compare?
All MPB devicesMPB Catheter, Hemodialysis, Non-Implanted: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MPB
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MPB
205in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MPB
4so far in 2026, the most since 2007
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · MPB
187in 2025
MAUDE reports naming product code MPB, 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 | 3 | 136 | 1 | 41 |
| 2008 | 0 | — | 0 | 147 |
| 2009 | 1 | — | 0 | 166 |
| 2010 | 1 | — | 0 | 60 |
| 2011 | 2 | — | 0 | 74 |
| 2012 | 1 | — | 0 | 78 |
| 2013 | 1 | — | 0 | 124 |
| 2014 | 0 | — | 0 | 82 |
| 2015 | 0 | — | 0 | 51 |
| 2016 | 1 | — | 0 | 70 |
| 2017 | 2 | — | 2 | 86 |
| 2018 | 0 | — | 0 | 120 |
| 2019 | 0 | — | 0 | 119 |
| 2020 | 3 | 205 | 0 | 179 |
| 2021 | 0 | — | 0 | 192 |
| 2022 | 0 | — | 0 | 166 |
| 2023 | 0 | — | 0 | 203 |
| 2024 | 0 | — | 0 | 181 |
| 2025 | 1 | — | 0 | 187 |
| 2026 | 0 | — | 4 (3) | — |
What is it indicated for?
The Medcomp Duo-Flow and Duo-Fiow 400 XL Double Lumen Catheters are designed for acute hemodialysis and apheresis. They may be inserted percutaneously and are ideally placed in the internal jugular vein. Although these catheters may be inserted into the subclavian or femoral vein, the internal jugular is the preferred site.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974236 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974236: Medcomp Schon XL Soft-Line Double Lumen Catheter, 15CM SBF146, Medcomp Schon XL Soft-Line Double Lumen Catheter, 20CM SB.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974236
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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