FDA 510(k)

Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety Needle

Numéro K : K260514 · 2026-06-12

Date de décision2026-06-12

Code produitFMF

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety Needle 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 2026-06-12 under 510(k) number K260514. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety Needle?

Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety Needle is a medical device that received FDA 510(k) clearance on 2026-06-12. The listed applicant is CMT Health PTE., Ltd.. The 510(k) number is K260514.

When did Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety Needle receive FDA 510(k) clearance?

Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety Needle received FDA 510(k) clearance on 2026-06-12, under 510(k) number K260514.

Who is the listed applicant for Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety Needle?

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 Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety Needle?

The FDA product code for Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety Needle is FMF.

Essais cliniques associés

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Autres dossiers indiquant CMT Health PTE., Ltd. en tant que demandeur

K262215Profoject™ Safety Sliding Blood Collection Set K261372Profoject™ LOR Syringe K261829Profoject™ Dual-Safety Pen Needles K260739Profoject™ Pen Needles (Model A; Model B)K260855Profoject™ Safety Pen Needles K253268Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes Cap

Voir tous les 12 dispositifs →

Dispositifs connexes (Code : FMF)

K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLC K252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc.K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLC K253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.K253112Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)Hlb Lifescience Co., Ltd.

Source officielle

Voir dans la base de données FDA →

Données issues de l'API ouverte de la FDA. Pour les informations les plus récentes et faisant autorité, veuillez toujours vous référer au registre officiel.