510(k) · Cleared
ClearedMedcomp Duo-Flow II Catheter with Lubricious Heparin
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 Nov 10, 1999 as substantially equivalent to K974236 (Medical Components, Inc., 1999) after a 205-day review. Its family tree reaches back 1 generation to 1999. 2 of the 18 devices in its family, counting itself, have a Class I recall. 16 later devices descend from it.
- Decided
- Nov 10, 1999
- Review
- 205 days
- Class
- Class II
- Product code
- MPB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K974236 (1999). 16 later devices descend from it, 3 citing it directly. 2 of the 18 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK974236 Medcomp Schon XL Soft-Line Double Lumen Catheter, 15CM SBF146…Medical Components, Inc. · 1999
- This deviceK991320 Medcomp Duo-Flow II Catheter with Lubricious HeparinMedical Components, Inc. · 1999
- Descendant · cites it directly · 7 of its ownK060509 Palindrome Emerald 14.5 FR Chronic Hemodialysis Catheter with…Tyco Healthcare Group · 2006 · Recalled
- Descendant · 2 generations on · 6 of its ownK062671 14.5 FR Chronic Hemodialysis Catheter with Heparin Coating and…Kendall · 2006 · Recalled
- Descendant · cites it directly · 6 of its ownK023914 Coaxia Flocontrol CatheterCoaxia, Inc. · 2003
- Descendant · 2 generations on · 5 of its ownK112477 Palindrome H, SI, Hsi Chronic CatheterCovidien · 2011 · Recalled (Class I)
- Descendant · 3 generations on · 4 of its ownK123196 Palindrome Precision H Chronic Catheter, Palindrome Precision SI…Covidien · 2013 · Recalled (Class I)
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 16 · See all- K060509Palindrome Emerald 14.5 FR Chronic Hemodialysis Catheter with Heparin CoatingTyco Healthcare Group · 2006 · cites it directly7descendants
- K06267114.5 FR Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve…Kendall · 2006 · 2 generations on6descendants
- K023914Coaxia Flocontrol CatheterCoaxia, Inc. · 2003 · cites it directly6descendants
- K112477Palindrome H, SI, Hsi Chronic CatheterCovidien · 2011 · 2 generations on5descendants
- K123196Palindrome Precision H Chronic Catheter, Palindrome Precision SI Chronic Catheter…Covidien · 2013 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K974236 | Medcomp Schon XL Soft-Line Double Lumen Catheter, 15CM SBF146, Medcomp Schon… | Medical Components, Inc. | 1999 | — |
| 0 (this device) | K991320 | Medcomp Duo-Flow II Catheter with Lubricious Heparin | Medical Components, Inc. | 1999 | — |
| +1 | K060509 | Palindrome Emerald 14.5 FR Chronic Hemodialysis Catheter with Heparin Coating | Tyco Healthcare Group | 2006 | 4 |
| +2 | K062671 | 14.5 FR Chronic Hemodialysis Catheter with Heparin Coating and Silver… | Kendall | 2006 | 24 |
| +1 | K023914 | Coaxia Flocontrol Catheter | Coaxia, Inc. | 2003 | — |
| +2 | K112477 | Palindrome H, SI, Hsi Chronic Catheter | Covidien | 2011 | Class I |
| +3 | K123196 | Palindrome Precision H Chronic Catheter, Palindrome Precision SI Chronic… | Covidien | 2013 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 1 |
| 2013 | 1 | 1 |
| 2014 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 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.
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? (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 |
|---|---|---|---|
| * | K974236 | Medcomp Schon XL Soft-Line Double Lumen Catheter, 15CM SBF146, Medcomp Schon XL…Summary page 1…1999 TRADE NAME: MedComp® DUO-COAT Catheter Double Lumen COMMON NAME: Hemodialysis Catheter, Non-Implanted SUBSTANTIALLY EQUIVALENT TO: Duo-Flow Double Lumen Catheter K974236 DESCRIPTION of the DEVICE: The MedComp® DUO-COAT Catheter Double Lumen combines the MEDCOMP Duo-Flow Catheter with a dual purpo… | 1999 |
What descends from it? (16)
See all 163 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 · 2 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 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 14 Class I recalls
What does this lineage say?
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-Coat Catheter is indicated for use in attaining short term vascular access for hemodialysis and apheresis. It may be inserted percutaneously and is ideally placed in the internal jugular vein of an adult patient. Alternate insertion site are the subclavian or femoral vein.
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/K991320 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991320: Medcomp Duo-Flow II Catheter with Lubricious Heparin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991320
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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