510(k) · Cleared
Recalled · 2008Diatek Cannon-Cath #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC, CC3200PC (32 CM), CC3200PC (36 CM)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diatek, Inc. · MSD Catheter, Hemodialysis, Implanted
Cleared on Aug 14, 2001 after a 186-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 of the 22 devices in its family, counting itself, have a Class I recall. 21 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 14, 2001
- Review
- 186 days
- Class
- Class II
- Product code
- MSD
- Recalls
- 2
- Predicates
- 0
21 later devices descend from it, 3 citing it directly. 5 of the 22 devices in this family, counting this one, have a Class I recall.
- This deviceK010399 Diatek Cannon-Cath #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC…Diatek, Inc. · 2001
- Descendant · cites it directly · 13 of its ownK040078 Cannon II PlusArrow International, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 11 of its ownK092205 Palindrome P Hemodialysis CatheterCovidien Lp, Formerly Registered AS Kendall · 2009
- Descendant · 3 generations on · 10 of its ownK111372 Tal Pallindrome (TM) Symmetric Tip Dual Lumen Catheter, Mahurkar (R)…Covidien · 2011 · Recalled (Class I)
- Descendant · 4 generations on · 5 of its ownK112477 Palindrome H, SI, Hsi Chronic CatheterCovidien · 2011 · Recalled (Class I)
- Descendant · cites it directly · 5 of its ownK040260 Integral Hemodialysis CatheterArrow Int'L. · 2004 · Recalled
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K141051 Vectorflow; Antegrade Chronic Hemodialysis…2 generations on · 2014
- K111372 Tal Pallindrome (TM) Symmetric Tip Dual Lumen…3 generations on · 2011
- K111900 Nextstep Antegrade Chronic Hemodialysis Catheter3 generations on · 2011
- K112477 Palindrome H, SI, Hsi Chronic Catheter4 generations on · 2011
Most influential descendants
Showing 5 of 21 · See all- K040078Cannon II PlusArrow International, Inc. · 2004 · cites it directly13descendants
- K092205Palindrome P Hemodialysis CatheterCovidien Lp, Formerly Registered AS Kendall · 2009 · 2 generations on11descendants
- K111372Tal Pallindrome (TM) Symmetric Tip Dual Lumen Catheter, Mahurkar (R) Maxid (TM) Dual…Covidien · 2011 · 3 generations on10descendants
- K112477Palindrome H, SI, Hsi Chronic CatheterCovidien · 2011 · 4 generations on5descendants
- K040260Integral Hemodialysis CatheterArrow Int'L. · 2004 · cites it directly5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010399 | Diatek Cannon-Cath #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC… | Diatek, Inc. | 2001 | — |
| +1 | K040078 | Cannon II Plus | Arrow International, Inc. | 2004 | 19 |
| +2 | K092205 | Palindrome P Hemodialysis Catheter | Covidien Lp, Formerly Registered AS Kendall | 2009 | — |
| +3 | K111372 | Tal Pallindrome (TM) Symmetric Tip Dual Lumen Catheter, Mahurkar (R) Maxid… | Covidien | 2011 | Class I |
| +4 | K112477 | Palindrome H, SI, Hsi Chronic Catheter | Covidien | 2011 | Class I |
| +1 | K040260 | Integral Hemodialysis Catheter | Arrow Int'L. | 2004 | 15 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 3 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 5 | 3 |
| 2013 | 2 | 1 |
| 2014 | 2 | 1 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
5 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 MSD device
- #1 K241581 Hemodialysis Catheterscore 12.4 · 11 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (21)
See all 213 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (5 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 10, 2008 | Not classified | Z-2242-2008 | Device Design | The tips may not have been adequately welded to the catheter body. |
| Sep 16, 2003 | Not classified | Z-0084-04 | Other | wrong product in box |
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.
- K141051Vectorflow; Antegrade Chronic Hemodialysis Catheter, Retrograde Chronic Hemodialysis Catheter, Retrograde…Arrow International, Inc. · 2014 · 2 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
- K111372Tal Pallindrome (TM) Symmetric Tip Dual Lumen Catheter, Mahurkar (R) Maxid (TM) Dual Lumen Catheter…Covidien · 2011 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
- K111900Nextstep Antegrade Chronic Hemodialysis CatheterTeleflexmedical, Inc. · 2011 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K112477Palindrome H, SI, Hsi Chronic CatheterCovidien · 2011 · 4 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, K040078 (Arrow International, Inc., 2004) has gone furthest, with 13 descendants of its own.
How does its category compare?
All MSD devicesMSD Catheter, Hemodialysis, Implanted: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MSD
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MSD
153in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MSD
1in 2013
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · MSD
1,054in 2025
MAUDE reports naming product code MSD, 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 | 7 | 92 | 0 | 118 |
| 2008 | 3 | 89 | 47 | 174 |
| 2009 | 6 | 81 | 49 | 173 |
| 2010 | 4 | 116 | 11 | 306 |
| 2011 | 7 | 70 | 24 | 268 |
| 2012 | 2 | — | 0 | 367 |
| 2013 | 5 | 105 | 1 | 363 |
| 2014 | 8 | 246 | 0 | 506 |
| 2015 | 1 | — | 0 | 550 |
| 2016 | 2 | — | 0 | 532 |
| 2017 | 2 | — | 0 | 484 |
| 2018 | 2 | — | 0 | 463 |
| 2019 | 1 | — | 0 | 645 |
| 2020 | 4 | 106 | 0 | 401 |
| 2021 | 4 | 153 | 0 | 523 |
| 2022 | 0 | — | 0 | 610 |
| 2023 | 0 | — | 0 | 542 |
| 2024 | 0 | — | 0 | 841 |
| 2025 | 1 | — | 0 | 1,054 |
| 2026 | 0 | — | 4 (4) | — |
https://510kreport.com/device/K010399 · printed Nov 4, 2026
Cite this page
510(k) Report. “K010399: Diatek Cannon-Cath #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC, CC3200PC (32 CM), CC3200PC (36 CM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K010399
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026