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FDA 510(k)

Profoject™ LOR Syringe

K-Number: K261372 · 2026-09-25

ApplicantCMT Health PTE., Ltd.
Decision Date2026-09-25
Product CodeCAZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Profoject™ LOR Syringe 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 K261372. The device is classified under product code CAZ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Profoject™ LOR Syringe?

Profoject™ LOR Syringe 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 K261372.

When did Profoject™ LOR Syringe receive FDA 510(k) clearance?

Profoject™ LOR Syringe received FDA 510(k) clearance on 2026-09-25, under 510(k) number K261372.

Who is the listed applicant for Profoject™ LOR Syringe?

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™ LOR Syringe?

The FDA product code for Profoject™ LOR Syringe is CAZ.

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.

K262215Profoject™ Safety Sliding Blood Collection SetK261829Profoject™ 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

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Related Devices (Code: CAZ)

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.

K222341Arrow 0.2 Micron Flat Filter, GVSArrow International, LLCK210983BD Epilor SyringeBecton, Dickinson and CompanyK201356Plastic LOR SyringeJiangsu Caina Medical Co.,LtdK202699E-Cath STIM acc. TsuiPAJUNK GmbH MedizintechnologieK190345VPCPAJUNK GmbH MedizintechnologieK161075Arrow Epidural Catheter KitTeleflexmedical, Inc.

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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