# K080807: Blood Tubing Sets (Sterile Fluid Path)

- Pathway: 510(k) (Special)
- Applicant: Nxstage Medical, Inc.
- Decided: Jul 18, 2008 after 119 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: 14 (7 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K953823 (1996). 1 ancestor in all.
9 later devices descend from it; 3 cite it directly.
1 of 11 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953823: Arterial Venous Blood Tubing Set, Medisystems Corp. (1996) Summary page 2.

## Most influential descendants
- K172238: CAREline Airless Hemodialysis Blood Tubing Sets (2017), 6 descendants of its own
- K201207: CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line (2020), 5 descendants of its own
- K231534: 5008X Hemodialysis System (2024), 2 descendants of its own
- K243505: 5008X Hemodialysis System (2025), 1 descendant of its own
- K213992: CombiSet Hemodialysis Blood Tubing Set (2023), 1 descendant of its own

## Recalls of this device
- Mar 19, 2026 · Class I · Z-1799-2026: Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
- Mar 19, 2026 · Class I · Z-1798-2026: Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
- Mar 19, 2026 · Class I · Z-1801-2026: Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
- Mar 19, 2026 · Class I · Z-1800-2026: Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
- Mar 19, 2026 · Class I · Z-1802-2026: Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
- Mar 19, 2026 · Class I · Z-1803-2026: Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
- Sep 30, 2025 · Class I · Z-0070-2026: The potential for micro-air bubbles observed in the bloodline and air-in-line alarms due to damaged arterial and venous patient connectors.
- Aug 15, 2024 · Class II · Z-3173-2024: Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rinseback procedures. If
- Aug 15, 2024 · Class II · Z-3175-2024: Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rinseback procedures. If
- Aug 15, 2024 · Class II · Z-3178-2024: Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rinseback procedures. If
- Aug 15, 2024 · Class II · Z-3179-2024: Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rinseback procedures. If
- Aug 15, 2024 · Class II · Z-3176-2024: Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rinseback procedures. If
- Aug 15, 2024 · Class II · Z-3174-2024: Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rinseback procedures. If
- Aug 15, 2024 · Class II · Z-3177-2024: Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rinseback procedures. If

## Indications for use
The blood tubing sets are indicated for use with a medically prescribed hemodialyzer. The suitability of a particular configuration is the responsibility of the physician in charge.

Source page: https://510kreport.com/device/K080807
Methodology: https://510kreport.com/methodology