# K983559: Blood Tubing Accessory with Clave Connector

- Pathway: 510(k) (Traditional)
- Applicant: Icu Medical, Inc.
- Decided: Dec 24, 1998 after 72 days
- Product code: FJK (Set, Tubing, Blood, With And Without Anti-Regurgitation Valve)
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: 54 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) MEDISYSTEMS ReadySet® Hemodialysis Blood Tubing Set, needle injection sites: named in the summary without a submission number

## Recalls of this device
- Aug 31, 2020 · Class II · Z-0711-2021: 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 me
- Jul 31, 2017 · Class II · Z-2649-2018: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

## Indications for use
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.

Source page: https://510kreport.com/device/K983559
Methodology: https://510kreport.com/methodology