510(k) · Cleared
ClearedJMS Blood Tubing Sets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jms North America Corp. · FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Cleared on Aug 16, 2004 as substantially equivalent to K001971 (Ofi Biomedica S.P.A., 2001) and 3 other predicates after a 327-day review. Its family tree reaches back 1 generation to 1985. 1 later device descends from it.
- Decided
- Aug 16, 2004
- Review
- 327 days
- Class
- Class II
- Product code
- FJK
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 1 generation to K852605 (1985). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K171952Dimesol Tubing Sets for HemodialysisDimesol, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K852605 | Blood Tubing Set | Medflex International, Inc. | 1985 | — |
| 0 (this device) | K032975 | JMS Blood Tubing Sets | Jms North America Corp. | 2004 | — |
| +1 | K171952 | Dimesol Tubing Sets for Hemodialysis | Dimesol, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 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? (5)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K010465 | FDA’s K010465 is Denstat Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2001 |
| * | K001971 | Hemodialysis Tubing SetsSummary page 1…intended use, design, safety and effectiveness: * Nipro® Blood Tubing Set (K01 465) * OFI Biomedica SpA Blood Tubing Set (K001971) *Nextron medical Technologies Blood Tubing Set (K852605) * Fresenius Blood Tubing Set (K001 107)… | 2001 |
| * | K852605 | Blood Tubing SetSummary page 1…* Nipro® Blood Tubing Set (K01 465) * OFI Biomedica SpA Blood Tubing Set (K001971) *Nextron medical Technologies Blood Tubing Set (K852605) * Fresenius Blood Tubing Set (K001 107) * Medisystems Blood Tubing Set (K953823)… | 1985 |
| * | K001107 | Fresenius Combilines Low Volume Blood Tubing Set, Models 03-2291 (Post Pump) and 03-2292…Summary page 1…* OFI Biomedica SpA Blood Tubing Set (K001971) *Nextron medical Technologies Blood Tubing Set (K852605) * Fresenius Blood Tubing Set (K001 107) * Medisystems Blood Tubing Set (K953823) 8 === Page 2 =… | 2000 |
| * | K953823 | Arterial Venous Blood Tubing SetSummary page 1…*Nextron medical Technologies Blood Tubing Set (K852605) * Fresenius Blood Tubing Set (K001 107) * Medisystems Blood Tubing Set (K953823) 8 510) Prcrnarkcl tNofificaio/… | 1996 |
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 |
|---|---|---|---|
| K171952 | Dimesol Tubing Sets for Hemodialysis | 2018 | 0 |
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?
- None of the 4 ancestors has a recall.
- Of its descendants, K171952 (Dimesol, Inc., 2018) has gone furthest, with 0 descendants of its own.
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 JMS Blood Tubing Sets with transducer protector and priming sets are disposable bloodlines intended to provide extracorporeal access to the patient's blood during hemodialysis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032975 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032975: JMS Blood Tubing Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032975
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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