PyloPlus Urea Breath Test System

FDA PMAFDA 510(k)

Class III (US FDA PMA)

PMA P170022510(k) K052708

by Arj Medical, Inc.

Identity

Trade Name: PyloPlus UBT System FDA PMA
Generic Name: Test, urea adult and pediatric (breath), FDA PMA

Identifiers

PMA Number: P170022 FDA PMA
510(k) Number: K052708 FDA PMA
FDA Product Code: LYR FDA PMA

Classification

Device Class: Class I FDA PMA
Legislation / Framework: 21 CFR Part 866.3110 FDA PMA
Regulation Number: 866.3110 FDA PMA
Advisory Committee: Microbiology FDA PMA
FDA Decision: SESE Substantially Equivalent FDA PMA

PyloPlus Urea Breath Test System by Arj Medical, Inc. (test, urea adult and pediatric (breath),) — Class III — FDA_510K, FDA_PMA — listed in FDA PMA, FDA 510(k)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

United States Active

FDA_PMA

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K052708	Class III	Active
FDA PMA	United States	FDA_PMA	P170022	Class III	Active

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Manufacturer

Manufacturer: Arj Medical, Inc.

Sources (2)

FDA PMA P170022 37 fields · synced Jun 18, 2026
FDA 510(k) K052708 1 fields · synced May 18, 2026