510(k) · Cleared
Recalled · Class II · 2015Nipro Blood Tubing Set with Transducer Protector and Priming Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nipro Medical Corporation · FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Cleared on Sep 28, 2012 as substantially equivalent to K072024 (Nipro Medical Corp., 2007) after a 385-day review. Its family tree reaches back 2 generations to 2001. It has been recalled once.
- Decided
- Sep 28, 2012
- Review
- 385 days
- Class
- Class II
- Product code
- FJK
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K010264 (2001). No later device cites it as a predicate yet.
- Root · 2 generations backK010264 Nipro Blood Tubing Set for Hemodialysis with Transducer Protectors…Nipro Medical Corp. · 2001
- 1 generation backK072024 Nipro Blood Tubing Set with Transducer Protector and Priming Set…Nipro Medical Corp. · 2007 · Recalled
- This deviceK112628 Nipro Blood Tubing Set with Transducer Protector and Priming SetNipro Medical Corporation · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010264 | Nipro Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming… | Nipro Medical Corp. | 2001 | — |
| −1 | K072024 | Nipro Blood Tubing Set with Transducer Protector and Priming Set, Model… | Nipro Medical Corp. | 2007 | 1 |
| 0 (this device) | K112628 | Nipro Blood Tubing Set with Transducer Protector and Priming Set | Nipro Medical Corporation | 2012 | — |
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 12.3 · 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 |
|---|---|---|---|
| * | K072024 | Nipro Blood Tubing Set with Transducer Protector and Priming Set, Model A201-A219…Summary page 1…alve Regulation Number: 21 CFR 876.5820 Panel: 78 Product Code: FJK 807.92(a)(3) Legally marketed substantial equivalent device: K072024 - NIPRO Set - Blood Tubing Set with Transducer Protector and Priming Set. 807.92 (a)(4) Description of device: T… | 2007 |
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 |
|---|---|---|---|---|
| Mar 30, 2015 | Class II | Z-0624-2016 | Device Design | Blood foaming was found during evaluation of the product. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 6.4 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 5 other devices also cite its predicate K072024.
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. 2012, this device’s year, is highlighted.
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 Nipro Set - SLIMLINE is a disposable bloodline 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/K112628 · printed Nov 3, 2026
Cite this page
510(k) Report. “K112628: Nipro Blood Tubing Set with Transducer Protector and Priming Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K112628
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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