510(k) · Cleared
Recalled · 2004Dual Lumen Catheter (DLC) Tray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neostar Medical Technologies, Inc. · KOC Accessories, Blood Circuit, Hemodialysis
Cleared on Mar 13, 1995 after a 333-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it. It has been recalled once.
- Decided
- Mar 13, 1995
- Review
- 333 days
- Class
- Class II
- Product code
- KOC
- Recalls
- 1
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK941851 Dual Lumen Catheter (DLC) TrayNeostar Medical Technologies, Inc. · 1995
- Descendant · cites it directly · 2 of its ownK963446 Kendall Dual Lumen CatheterKendall Healthcare Products Co. Div.Of Tyco Health · 1997
- Descendant · 2 generations on · 1 of its ownK063355 D-Line Catheter ST, Double Lumen ST; Extra FlowNovosci Corp. · 2007
- Descendant · 3 generations on · 0 of its ownK102833 Disposable Hemodialysis Access Catheter SetsFoshan Nanhai Bai HE Medical Technology Co., Ltd. · 2011
- Descendant · cites it directly · 0 of its ownK952660 Braun Hemodialysis CatheterB.Braun Medical, Inc. · 1996
Most influential descendants
Showing 4 of 4 · See all- K963446Kendall Dual Lumen CatheterKendall Healthcare Products Co. Div.Of Tyco Health · 1997 · cites it directly2descendants
- K063355D-Line Catheter ST, Double Lumen ST; Extra FlowNovosci Corp. · 2007 · 2 generations on1descendant
- K102833Disposable Hemodialysis Access Catheter SetsFoshan Nanhai Bai HE Medical Technology Co., Ltd. · 2011 · 3 generations on0descendants
- K952660Braun Hemodialysis CatheterB.Braun Medical, Inc. · 1996 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K941851 | Dual Lumen Catheter (DLC) Tray | Neostar Medical Technologies, Inc. | 1995 | — |
| +1 | K963446 | Kendall Dual Lumen Catheter | Kendall Healthcare Products Co. Div.Of Tyco Health | 1997 | — |
| +2 | K063355 | D-Line Catheter ST, Double Lumen ST; Extra Flow | Novosci Corp. | 2007 | — |
| +3 | K102833 | Disposable Hemodialysis Access Catheter Sets | Foshan Nanhai Bai HE Medical Technology Co., Ltd. | 2011 | — |
| +1 | K952660 | Braun Hemodialysis Catheter | B.Braun Medical, Inc. | 1996 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 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.
Planning a device in KOC? 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 KOC device
- #1 K230514 Blood Tubing Lines for Hemodialysis AL Series…score 11.8 · 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 28, 2004 | Not classified | Z-1029-04 | Other | The products have a potential defective seal that closes the product's OUTER POUCH. The surface of the INNER TRAY may no longer be sterile. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K963446 (Kendall Healthcare Products Co. Div.Of Tyco Health, 1997) has gone furthest, with 2 descendants of its own.
How does its category compare?
All KOC devicesKOC Accessories, Blood Circuit, Hemodialysis: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KOC
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KOC
Too few KOC 510(k)s in any year since 2007 to give a median.
Recalls per year · KOC
4so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KOC
50in 2025
MAUDE reports naming product code KOC, 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 | 1 | — | 0 | 3 |
| 2008 | 2 | — | 2 | 12 |
| 2009 | 2 | — | 0 | 12 |
| 2010 | 0 | — | 0 | 4 |
| 2011 | 0 | — | 0 | 10 |
| 2012 | 1 | — | 1 | 2 |
| 2013 | 0 | — | 0 | 22 |
| 2014 | 1 | — | 1 | 165 |
| 2015 | 2 | — | 0 | 555 |
| 2016 | 1 | — | 0 | 10 |
| 2017 | 1 | — | 0 | 23 |
| 2018 | 0 | — | 3 | 37 |
| 2019 | 0 | — | 0 | 56 |
| 2020 | 1 | — | 0 | 20 |
| 2021 | 0 | — | 0 | 33 |
| 2022 | 0 | — | 0 | 26 |
| 2023 | 2 | — | 0 | 16 |
| 2024 | 0 | — | 0 | 18 |
| 2025 | 2 | — | 0 | 50 |
| 2026 | 0 | — | 4 | — |
https://510kreport.com/device/K941851 · printed Nov 6, 2026
Cite this page
510(k) Report. “K941851: Dual Lumen Catheter (DLC) Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K941851
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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