Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Profoject™ Safety Sliding Blood Collection Set

K-Number: K262215 · 2026-09-25

ApplicantCMT Health PTE., Ltd.
Decision Date2026-09-25
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Profoject™ Safety Sliding Blood Collection Set is the device name listed in this FDA 510(k) record. The listed applicant is CMT Health PTE., Ltd.. It received FDA 510(k) clearance on 2026-09-25 under 510(k) number K262215. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Profoject™ Safety Sliding Blood Collection Set?

Profoject™ Safety Sliding Blood Collection Set is a medical device that received FDA 510(k) clearance on 2026-09-25. The listed applicant is CMT Health PTE., Ltd.. The 510(k) number is K262215.

When did Profoject™ Safety Sliding Blood Collection Set receive FDA 510(k) clearance?

Profoject™ Safety Sliding Blood Collection Set received FDA 510(k) clearance on 2026-09-25, under 510(k) number K262215.

Who is the listed applicant for Profoject™ Safety Sliding Blood Collection Set?

The FDA 510(k) record lists CMT Health PTE., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Profoject™ Safety Sliding Blood Collection Set?

The FDA product code for Profoject™ Safety Sliding Blood Collection Set is JKA.

Other records listing CMT Health PTE., Ltd. as applicant

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.

K261372Profoject™ LOR SyringeK261829Profoject™ Dual-Safety Pen NeedlesK260739Profoject™ Pen Needles (Model A; Model B)K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleK260855Profoject™ Safety Pen NeedlesK253268Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes Cap

View all 12 devices →

Related Devices (Code: JKA)

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.

K252899Female Culture Device; Male Culture Device; Transfer Device; Access DeviceZhejiang Kindly Medical Device Co., Ltd.K260128BD Preset™ and BD A-Line™ Arterial Blood Collection SyringesBecton, Dickinson and CompanyK252506BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached HolderBecton, Dickinson and CompanyK252378BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection TubeBecton, Dickinson and CompanyK252040BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection TubesBecton, Dickinson and CompanyK251812Steripath® Flow™ Blood Collection SystemMagnolia Medical Technologies

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.

↑