510(k) · Cleared
ClearedKendall Dual Lumen Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kendall Healthcare Products Co. Div.Of Tyco Health · MPB Catheter, Hemodialysis, Non-Implanted
Cleared on Mar 18, 1997 as substantially equivalent to K941851 (Neostar Medical Technologies, Inc., 1995) after a 196-day review. Its family tree reaches back 1 generation to 1995. 2 later devices descend from it.
- Decided
- Mar 18, 1997
- Review
- 196 days
- Class
- Class II
- Product code
- MPB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K941851 (1995). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK941851 Dual Lumen Catheter (DLC) TrayNeostar Medical Technologies, Inc. · 1995 · Recalled
- This deviceK963446 Kendall Dual Lumen CatheterKendall Healthcare Products Co. Div.Of Tyco Health · 1997
- Descendant · cites it directly · 1 of its ownK063355 D-Line Catheter ST, Double Lumen ST; Extra FlowNovosci Corp. · 2007
- Descendant · 2 generations on · 0 of its ownK102833 Disposable Hemodialysis Access Catheter SetsFoshan Nanhai Bai HE Medical Technology Co., Ltd. · 2011
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K941851 | Dual Lumen Catheter (DLC) Tray | Neostar Medical Technologies, Inc. | 1995 | 1 |
| 0 (this device) | K963446 | Kendall Dual Lumen Catheter | Kendall Healthcare Products Co. Div.Of Tyco Health | 1997 | — |
| +1 | K063355 | D-Line Catheter ST, Double Lumen ST; Extra Flow | Novosci Corp. | 2007 | — |
| +2 | K102833 | Disposable Hemodialysis Access Catheter Sets | Foshan Nanhai Bai HE Medical Technology Co., Ltd. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2011 | 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 MPB? 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 |
|---|---|---|---|
| * | K941851 | Dual Lumen Catheter (DLC) TraySummary page 1…Kendall Dual Lumen Catheters are substantially equivaient in form, fit, function and intended use to the commercially available Neostar Dual Lumen Catheters, 510(k) No. K941851. 4. Description of Device The Kendall Dual Lumen Catheters are single use, sterile devices. The single radiopaque cannula cath… | 1995 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063355 | D-Line Catheter ST, Double Lumen ST; Extra Flow | 2007 | 1 |
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?
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 Kendall Dual Lumen Catheters are intended for use as short-term vascular access for hemodialysis. The catheters can be inserted in the femoral, subclavian or jugular vein as required.
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/K963446 · printed Nov 4, 2026
Cite this page
510(k) Report. “K963446: Kendall Dual Lumen Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963446
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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