510(k) · Decided
DecidedD-Line Catheter ST, Double Lumen ST; Extra Flow
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novosci Corp. · MPB Catheter, Hemodialysis, Non-Implanted
Cleared on Jul 27, 2007 as substantially equivalent to K963446 (Kendall Healthcare Products Co. Div.Of Tyco Health, 1997) and 2 other predicates after a 262-day review. Its family tree reaches back 2 generations to 1995. 1 of the 6 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Jul 27, 2007
- Review
- 262 days
- Class
- Class II
- Product code
- MPB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K941851 (1995). 4 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 6 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK941851 Dual Lumen Catheter (DLC) TrayNeostar Medical Technologies, Inc. · 1995 · Recalled
- 1 generation backK963446 Kendall Dual Lumen CatheterKendall Healthcare Products Co. Div.Of Tyco Health · 1997
- This deviceK063355 D-Line Catheter ST, Double Lumen ST; Extra FlowNovosci Corp. · 2007
- Descendant · cites it directly · 0 of its ownK102833 Disposable Hemodialysis Access Catheter SetsFoshan Nanhai Bai HE Medical Technology Co., Ltd. · 2011
Class I recalls in this family
- K030209 Mahurkar Oplus Catheter, Model 13.5 FRdirect predicate · 2003
Most influential descendants
Showing 1 of 1 · See all- K102833Disposable Hemodialysis Access Catheter SetsFoshan Nanhai Bai HE Medical Technology Co., Ltd. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K941851 | Dual Lumen Catheter (DLC) Tray | Neostar Medical Technologies, Inc. | 1995 | 1 |
| −1 | K963446 | Kendall Dual Lumen Catheter | Kendall Healthcare Products Co. Div.Of Tyco Health | 1997 | — |
| 0 (this device) | K063355 | D-Line Catheter ST, Double Lumen ST; Extra Flow | Novosci Corp. | 2007 | — |
| +1 | K102833 | Disposable Hemodialysis Access Catheter Sets | Foshan Nanhai Bai HE Medical Technology Co., Ltd. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2003 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
1 device in this family has 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? (3)
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 |
|---|---|---|---|
| * | K963446 | Kendall Dual Lumen CatheterSummary page 1…ation Name: 78 MPB-Catheter, Hemodialysis, Non-implanted 21 CFR 876.5540 (b)(2) 3. Predicate Device Kendall Mahurkar Catheter, K963446 Kendall Mahurkar QPlus Catheter, K030209 Medcomp Duo-flow Catheter, K974236 4. Description of Device The Joline… | 1997 |
| * | K030209 | Mahurkar Oplus Catheter, Model 13.5 FRSummary page 1…n-implanted 21 CFR 876.5540 (b)(2) 3. Predicate Device Kendall Mahurkar Catheter, K963446 Kendall Mahurkar QPlus Catheter, K030209 Medcomp Duo-flow Catheter, K974236 4. Description of Device The Joline D-Line Catheter ST family of catheters, consist… | 2003 |
| * | K974236 | Medcomp Schon XL Soft-Line Double Lumen Catheter, 15CM SBF146, Medcomp Schon XL…Summary page 1…21 CFR 876.5540 (b)(2) 3. Predicate Device Kendall Mahurkar Catheter, K963446 Kendall Mahurkar QPlus Catheter, K030209 Medcomp Duo-flow Catheter, K974236 4. Description of Device The Joline D-Line Catheter ST family of catheters, consisting of the Dual Lumen Short Term Hemodi… | 1999 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102833 | Disposable Hemodialysis Access Catheter Sets | 2011 | 0 |
Has anything in its family been recalled? (1 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.
- K030209Mahurkar Oplus Catheter, Model 13.5 FRThe Kendall Company · 2003 · Direct predicate · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 10.4 years on median.
- 2 of the 4 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K102833 (Foshan Nanhai Bai HE Medical Technology Co., Ltd., 2011) has gone furthest, with 0 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. 2007, this device’s year, is highlighted.
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 Dual Lumen Short Term Hemodialysis and Extra Flow (EF) Short Term Hemodialysis catheters are indicated for use in hemodialysis, hemoperfusion and apheresis for short-term duration of less than 30 days via the subclavian, femoral or jugular vein
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063355 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063355: D-Line Catheter ST, Double Lumen ST; Extra Flow.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063355
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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