510(k) · Cleared
Recalled · 2007Braun Hemodialysis Blood Circuits
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B.Braun Medical, Inc. · FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Cleared on Apr 30, 1996 as substantially equivalent to K884243 (Mediflex Intl., 1988) after a 327-day review. Its family tree reaches back 1 generation to 1988. It has been recalled 2 times.
- Decided
- Apr 30, 1996
- Review
- 327 days
- Class
- Class II
- Product code
- FJK
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K884243 (1988). No later device cites it as a predicate yet.
- Root · 1 generation backK884243 Blood Tubing SetMediflex Intl. · 1988
- This deviceK952631 Braun Hemodialysis Blood CircuitsB.Braun Medical, Inc. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K884243 | Blood Tubing Set | Mediflex Intl. | 1988 | — |
| 0 (this device) | K952631 | Braun Hemodialysis Blood Circuits | B.Braun Medical, Inc. | 1996 | — |
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 FJK? 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 FJK device
- #1 K252423 NovaLine Tubing Set for Hemodialysis (BL 124)score 12.2 · 4 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 |
|---|---|---|---|
| * | K884243 | Blood Tubing SetSummary page 1…SSIFICATION NAME: Gastroenterology and Urology Class II, 78 KOC,Hemodialysis Blood Circuits 21 CFR 876.5820 SUBSTANTIAL EQUIVALENCE' TO: 510(k) number Name Applicant K884243 Blood Tubing Set Mediflex International Inc. DEVICE DESCRIPTION: B. Braun Medical Inc. intends to introduce into interstate co… | 1988 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 10, 2007 | Not classified | Z-1035-2008 | Process control | Faulty tubing does not prime machine as intended. |
| Dec 10, 2007 | Not classified | Z-1036-2008 | Process control | Faulty tubing does not prime machine as intended. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All FJK devicesFJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FJK
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FJK
255in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FJK
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · FJK
1,487in 2025
MAUDE reports naming product code FJK, 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 | 4 | 116 | 2 | 135 |
| 2008 | 1 | — | 2 | 86 |
| 2009 | 1 | — | 0 | 76 |
| 2010 | 1 | — | 2 | 130 |
| 2011 | 0 | — | 0 | 243 |
| 2012 | 2 | — | 0 | 35 |
| 2013 | 0 | — | 0 | 114 |
| 2014 | 1 | — | 0 | 116 |
| 2015 | 0 | — | 1 | 126 |
| 2016 | 1 | — | 0 | 139 |
| 2017 | 1 | — | 0 | 131 |
| 2018 | 1 | — | 0 | 119 |
| 2019 | 0 | — | 0 | 185 |
| 2020 | 0 | — | 1 | 190 |
| 2021 | 3 | 255 | 0 | 188 |
| 2022 | 0 | — | 0 | 362 |
| 2023 | 1 | — | 0 | 585 |
| 2024 | 1 | — | 0 | 417 |
| 2025 | 1 | — | 1 (1) | 1,487 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The configurations can be summarized tubing segments intended for use in transporting blood from a patient's vascular access device to hemodialyzer systems. Also, the tubing segments intended for use in transporting blood to a patient's vascular access device from such a system.
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/K952631 · printed Nov 6, 2026
Cite this page
510(k) Report. “K952631: Braun Hemodialysis Blood Circuits.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K952631
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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