# K251341: VITAL Tubing Sets for Hemodialysis

- Pathway: 510(k) (Traditional)
- Applicant: Vital Healthcare Sdn. Bhd.
- Decided: Jan 16, 2026 after 261 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K010264 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201866: NovaLine Tubing Sets for Hemodialysis, Bain Medical Equipment (Guangzhou) Co., Ltd. (2021) Summary page 7.

## Indications for use
The VITAL Tubing Sets for Hemodialysis are sterile, single-use arterial and venous blood lines for exclusive use with AK98 (model BLU014E, BLU015E, BLU021E, BLU022E, BLU025E), Fresenius 2008 series (model BLU001E, BLU002E, BLU003E, BLU004E, BLU005E, BLU006E, BLU007E, BLU008E, BLU009E, BLU010E, BLU011E, BLU012E, BLU013E, BLU016E, BLU017E, BLU018E, BLU020E, BLU023E, BLU024E, BLU029E, BLU030E, BLU063E), Fresenius 5008X (model BLU026E, BLU027E) or Bbraun Dialog series Hemodialysis system (model BLU019E, BLU028E). The blood lines serve as the extracorporeal blood circuit in patients undergoing hemodialysis treatment, by which blood is transported from the patient through a hemodialyzer and back to the patient. The pump line interfaces with a pump rotor mechanism of the hemodialysis machine which drives the flow of blood through the circuit.

Source page: https://510kreport.com/device/K251341
Methodology: https://510kreport.com/methodology