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FDA 510(k)

VITAL Tubing Sets for Hemodialysis

K-Number: K251341 · 2026-01-16

ApplicantVital Healthcare Sdn. Bhd.
Decision Date2026-01-16
Product CodeFJK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

VITAL Tubing Sets for Hemodialysis is the device name listed in this FDA 510(k) record. The listed applicant is Vital Healthcare Sdn. Bhd.. It received FDA 510(k) clearance on 2026-01-16 under 510(k) number K251341. 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 VITAL Tubing Sets for Hemodialysis?

VITAL Tubing Sets for Hemodialysis is a medical device that received FDA 510(k) clearance on 2026-01-16. The listed applicant is Vital Healthcare Sdn. Bhd.. The 510(k) number is K251341.

When did VITAL Tubing Sets for Hemodialysis receive FDA 510(k) clearance?

VITAL Tubing Sets for Hemodialysis received FDA 510(k) clearance on 2026-01-16, under 510(k) number K251341.

Who is the listed applicant for VITAL Tubing Sets for Hemodialysis?

The FDA 510(k) record lists Vital Healthcare Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VITAL Tubing Sets for Hemodialysis?

The FDA product code for VITAL Tubing Sets for Hemodialysis is FJK.

Related Devices (Code: FJK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252423NovaLine Tubing Set for Hemodialysis (BL 124)Bain Medical Equipment (Guangzhou) Co., Ltd.K251442TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)Ningbo Tianyi Medical Appliance Co., Ltd.K243607Moda-flx Hemodialysis System™ Cartridge (102121-001 )Diality, Inc.K213992CombiSet Hemodialysis Blood Tubing SetFresenius Medical Care Renal Therapies Group, LLCK210782Tablo CartridgeOutset Medical, Inc.K202796SANSIN Tubing Sets for HemodialysisJiangxi Sanxin Medtec Co., Ltd.

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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