510(k) · Cleared
ClearedDisposable Hemodialysis Access Catheter Sets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Foshan Nanhai Bai HE Medical Technology Co., Ltd. · MPB Catheter, Hemodialysis, Non-Implanted
Cleared on Nov 18, 2011 as substantially equivalent to K090102 (C.R. Bard, Inc., 2009) and 1 other predicate after a 415-day review. Its family tree reaches back 3 generations to 1995. 2 of the 11 devices in its family, counting itself, have a Class I recall.
- Decided
- Nov 18, 2011
- Review
- 415 days
- Class
- Class II
- Product code
- MPB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K941851 (1995). 10 ancestors in all, the oldest K871488 (1987). No later device cites it as a predicate yet. 2 of the 11 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK941851 Dual Lumen Catheter (DLC) TrayNeostar Medical Technologies, Inc. · 1995 · Recalled
- 2 generations backK963446 Kendall Dual Lumen CatheterKendall Healthcare Products Co. Div.Of Tyco Health · 1997
- 1 generation backK063355 D-Line Catheter ST, Double Lumen ST; Extra FlowNovosci Corp. · 2007
- This deviceK102833 Disposable Hemodialysis Access Catheter SetsFoshan Nanhai Bai HE Medical Technology Co., Ltd. · 2011
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K941851 | Dual Lumen Catheter (DLC) Tray | Neostar Medical Technologies, Inc. | 1995 | 1 |
| −2 | 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 | — |
| 0 (this device) | 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 |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 1 |
| 2009 | 1 | 1 |
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? (2)
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 |
|---|---|---|---|
| * | K090102 | Niagara, Niagara Slim-Cath, and Brevia Short-Term Curved Extension Hemodialysis CathetersSummary page 2…during its shelf life. 6. Substantially Equivalent Predicate Device 1: Niagara®g, Niagara®R Slim-Cath®g, Breviag Dual Lumen Catheters 510(k) Number: K090102 Predicate Device 2: Joline D-Line Catheter STfamily of catheters in kits consisting of Dual Lume… | 2009 |
| * | K063355 | D-Line Catheter ST, Double Lumen ST; Extra FlowSummary page 2…of Dual Lumen Short Term Hemodialysis Catheter Extra Flow (F) Short Term Hemodialysis Catheter 51 0(k) Number: K(063355 SE Claim: the proposed device, Disposable Hemodialysis Access Catheter Set, is claimed to be substantially equivale… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- K090102Niagara, Niagara Slim-Cath, and Brevia Short-Term Curved Extension Hemodialysis CathetersC.R. Bard, Inc. · 2009 · Direct predicate · ◆ in the 2009 ancestors bar of FIG. 11 Class I recall
- K030209Mahurkar Oplus Catheter, Model 13.5 FRThe Kendall Company · 2003 · 2 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 4.3 years on median.
- 3 of the 10 ancestors have a recall of any class; 2 have a Class I recall.
How does its category compare?
All MPB devicesMPB Catheter, Hemodialysis, Non-Implanted: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
Disposable H-emodialysis Access Catheter Sets, including single lumen and dual lumen, are indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis via the internal jugular, stzbclavian or femoral vein.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102833 · printed Nov 4, 2026
Cite this page
510(k) Report. “K102833: Disposable Hemodialysis Access Catheter Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K102833
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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