510(k) · Cleared
Recalled · Class II · 2020Blood Tubing Accessory with Clave Connector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Icu Medical, Inc. · FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Cleared on Dec 24, 1998 after a 72-day review. The FDA summary names its predicate without a number. It has been recalled 54 times.
- Decided
- Dec 24, 1998
- Review
- 72 days
- Class
- Class II
- Product code
- FJK
- Recalls
- 54
- Predicates
- 0
The FDA summary names its predicate without a number.
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 |
|---|---|---|---|
| * | — | MEDISYSTEMS ReadySet® Hemodialysis Blood Tubing Set, needle injection sites Named without a submission number |
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 |
|---|---|---|---|---|
| Aug 31, 2020 | Class II | Z-0711-2021 | Process control | Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to… |
| Jul 31, 2017 | Class II | Z-2649-2018 | Labeling mix-ups | Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. |
| Jul 31, 2017 | Class II | Z-2611-2018 | Labeling mix-ups | Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. |
| Jul 31, 2017 | Class II | Z-2647-2018 | Labeling mix-ups | Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. |
| Jul 31, 2017 | Class II | Z-2653-2018 | Labeling mix-ups | Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. |
| Jul 31, 2017 | Class II | Z-2652-2018 | Labeling mix-ups | Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. |
| Jul 31, 2017 | Class II | Z-2613-2018 | Labeling mix-ups | Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. |
| Jul 31, 2017 | Class II | Z-2624-2018 | Labeling mix-ups | Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. |
| Jul 31, 2017 | Class II | Z-2634-2018 | Labeling mix-ups | Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. |
| Jul 31, 2017 | Class II | Z-2632-2018 | Labeling mix-ups | Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. |
| Jul 31, 2017 | Class II | Z-2651-2018 | Labeling mix-ups | Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. |
| Jul 31, 2017 | Class II | Z-2614-2018 | Labeling mix-ups | Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. |
| Jul 31, 2017 | Class II | Z-2608-2018 | Labeling mix-ups | Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. |
| Jul 31, 2017 | Class II | Z-2635-2018 | Labeling mix-ups | Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. |
| Jul 31, 2017 | Class II | Z-2625-2018 | Labeling mix-ups | Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. |
| Jul 31, 2017 | Class II | Z-2617-2018 | Labeling mix-ups | Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. |
| Jul 31, 2017 | Class II | Z-2609-2018 | Labeling mix-ups | Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. |
| Jul 31, 2017 | Class II | Z-2657-2018 | Labeling mix-ups | Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. |
| Jul 31, 2017 | Class II | Z-2639-2018 | Labeling mix-ups | Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. |
| Jul 31, 2017 | Class II | Z-2623-2018 | Labeling mix-ups | Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. |
| Jul 31, 2017 | Class II | Z-2621-2018 | Labeling mix-ups | Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. |
| Jul 31, 2017 | Class II | Z-2642-2018 | Labeling mix-ups | Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. |
| Jul 31, 2017 | Class II | Z-2606-2018 | Labeling mix-ups | Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. |
| Jul 31, 2017 | Class II | Z-2630-2018 | Labeling mix-ups | Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. |
| Jul 31, 2017 | Class II | Z-2618-2018 | Labeling mix-ups | Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. |
| Jul 31, 2017 | Class II | Z-2654-2018 | Labeling mix-ups | Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. |
| Jul 31, 2017 | Class II | Z-2658-2018 | Labeling mix-ups | Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. |
| Jul 31, 2017 | Class II | Z-2640-2018 | Labeling mix-ups | Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. |
| Jul 31, 2017 | Class II | Z-2629-2018 | Labeling mix-ups | Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. |
| Jul 31, 2017 | Class II | Z-2637-2018 | Labeling mix-ups | Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. |
| Jul 31, 2017 | Class II | Z-2622-2018 | Labeling mix-ups | Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. |
| Jul 31, 2017 | Class II | Z-2610-2018 | Labeling mix-ups | Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. |
| Jul 31, 2017 | Class II | Z-2612-2018 | Labeling mix-ups | Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. |
| Jul 31, 2017 | Class II | Z-2607-2018 | Labeling mix-ups | Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. |
| Jul 31, 2017 | Class II | Z-2644-2018 | Labeling mix-ups | Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. |
| Jul 31, 2017 | Class II | Z-2620-2018 | Labeling mix-ups | Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. |
| Jul 31, 2017 | Class II | Z-2633-2018 | Labeling mix-ups | Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. |
| Jul 31, 2017 | Class II | Z-2656-2018 | Labeling mix-ups | Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. |
| Jul 31, 2017 | Class II | Z-2648-2018 | Labeling mix-ups | Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. |
| Jul 31, 2017 | Class II | Z-2627-2018 | Labeling mix-ups | Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. |
| Jul 31, 2017 | Class II | Z-2626-2018 | Labeling mix-ups | Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. |
| Jul 31, 2017 | Class II | Z-2628-2018 | Labeling mix-ups | Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. |
| Jul 31, 2017 | Class II | Z-2650-2018 | Labeling mix-ups | Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. |
| Jul 31, 2017 | Class II | Z-2615-2018 | Labeling mix-ups | Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. |
| Jul 31, 2017 | Class II | Z-2641-2018 | Labeling mix-ups | Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. |
| Jul 31, 2017 | Class II | Z-2638-2018 | Labeling mix-ups | Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. |
| Jul 31, 2017 | Class II | Z-2655-2018 | Labeling mix-ups | Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. |
| Jul 31, 2017 | Class II | Z-2643-2018 | Labeling mix-ups | Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. |
| Jul 31, 2017 | Class II | Z-2645-2018 | Labeling mix-ups | Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. |
| Jul 31, 2017 | Class II | Z-2636-2018 | Labeling mix-ups | Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. |
The 5 latest of 50 recalls; the web page lists all.
No ancestor or descendant has a Class I 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 Blood Tubing Accessory with CLAVE Connector” is intended for use in hemodialysis and other chronic applications where blood sampling is required. Luer-locking adaptors allow secure, in-line placement between the blood tubing set and the catheter or venipuncture device. Use of a CLAVE Connector allows the clinician needle-free blood withdrawal.
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/K983559 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983559: Blood Tubing Accessory with Clave Connector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983559
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026