# K161582: DORA Tubing Sets for Hemodialysis

- Pathway: 510(k) (Traditional)
- Applicant: Bain Medical Equipment (Guangzhou) Co., Ltd.
- Decided: Jun 16, 2017 after 373 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: 2 generations back to K010264 (2001). 2 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072024: Nipro Blood Tubing Set with Transducer Protector and Priming Set, Model A201-A219, V801-V806, 5M9634, 5M9693, Nipro Medical Corp. (2007) Summary page 5.

## Most influential descendants
- K201866: NovaLine Tubing Sets for Hemodialysis (2021), 2 descendants of its own
- K252423: NovaLine Tubing Set for Hemodialysis (BL 124) (2026), 0 descendants of its own
- K251341: VITAL Tubing Sets for Hemodialysis (2026), 0 descendants of its own
- K202796: SANSIN Tubing Sets for Hemodialysis (2021), 0 descendants of its own

## Indications for use
The DORA Tubing Sets for Hemodialysis are single-use sterile medical devices intended to connect the patient to the hemodialyzer and the hemodialysis delivery system in hemodialysis treatment. The compatibility of available configurations is the responsibility of the physician/clinician in charge.

Source page: https://510kreport.com/device/K161582
Methodology: https://510kreport.com/methodology