510(k) · Cleared
ClearedBraun Hemodialysis Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B.Braun Medical, Inc. · MPB Catheter, Hemodialysis, Non-Implanted
Cleared on Sep 17, 1996 as substantially equivalent to K893439 (Medical Components, Inc., 1989) and 1 other predicate after a 463-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- Sep 17, 1996
- Review
- 463 days
- Class
- Class II
- Product code
- MPB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K893439 (1989). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK893439 Hemo-Cath Silicone Double Lumen Cath SL28C & SL40CMedical Components, Inc. · 1989 · Recalled
- This deviceK952660 Braun Hemodialysis CatheterB.Braun Medical, Inc. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K893439 | Hemo-Cath Silicone Double Lumen Cath SL28C & SL40C | Medical Components, Inc. | 1989 | 5 |
| 0 (this device) | K952660 | Braun Hemodialysis Catheter | B.Braun Medical, Inc. | 1996 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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? (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 |
|---|---|---|---|
| * | K893439 | Hemo-Cath Silicone Double Lumen Cath SL28C & SL40CSummary page 1…s CLASSIFICATION NAME: Gastroenterology and Urology Class II, 78 LFJ, Subclavian Catheter 21 CFR 876.5540 SUBSTANTIAL EQUIVALENCEl TO: 510(k) number Name Applicant K893439 HEMO-CATH SILICONE MEDICAL DOUBLE LUMEN CATH COMPONENTS, INC. SL28C & SL40C K941851 DUAL LUMEN CATHETER | NEOSTAR MEDICAL (DLC)… | 1989 |
| * | K941851 | Dual Lumen Catheter (DLC) TraySummary page 1…theter 21 CFR 876.5540 SUBSTANTIAL EQUIVALENCEl TO: 510(k) number Name Applicant K893439 HEMO-CATH SILICONE MEDICAL DOUBLE LUMEN CATH COMPONENTS, INC. SL28C & SL40C K941851 DUAL LUMEN CATHETER | NEOSTAR MEDICAL (DLC) TRAY TECHNOLOGIES, INC. DEVICE DESCRIPTION: B. Braun of America Inc. intends to int… | 1995 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- 2 of the 2 ancestors have a recall of any class.
- 1 other device also cites its predicate K893439.
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 intended use is to allow access to the central venous system for blood circulation in pheresis or apheresis processes(i.e. Hemodialysis).
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/K952660 · printed Nov 4, 2026
Cite this page
510(k) Report. “K952660: Braun Hemodialysis Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K952660
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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