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FDA 510(k)

NovaLine Tubing Set for Hemodialysis (BL 124)

K-Number: K252423 · 2026-05-15

ApplicantBain Medical Equipment (Guangzhou) Co., Ltd.
Decision Date2026-05-15
Product CodeFJK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NovaLine Tubing Set for Hemodialysis (BL 124) is a medical device manufactured by Bain Medical Equipment (Guangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2026-05-15 under approval number K252423. The device is classified under product code FJK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NovaLine Tubing Set for Hemodialysis (BL 124)?

NovaLine Tubing Set for Hemodialysis (BL 124) is a medical device that received FDA 510(k) clearance on 2026-05-15. It is manufactured by Bain Medical Equipment (Guangzhou) Co., Ltd.. The 510(k) number is K252423.

When was NovaLine Tubing Set for Hemodialysis (BL 124) approved by the FDA?

NovaLine Tubing Set for Hemodialysis (BL 124) received FDA 510(k) clearance on 2026-05-15, under approval number K252423.

What company makes NovaLine Tubing Set for Hemodialysis (BL 124)?

NovaLine Tubing Set for Hemodialysis (BL 124) is manufactured by Bain Medical Equipment (Guangzhou) Co., Ltd..

What is the FDA product code for NovaLine Tubing Set for Hemodialysis (BL 124)?

The FDA product code for NovaLine Tubing Set for Hemodialysis (BL 124) is FJK.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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