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

FDA 510(k)

ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)

K-Number: K252281 · 2025-11-18

ApplicantUlrich GmbH & Co. KG
Decision Date2025-11-18
Product CodeIZQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) is a medical device manufactured by Ulrich GmbH & Co. KG. It received FDA 510(k) clearance on 2025-11-18 under approval number K252281. The device is classified under product code IZQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)?

ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) is a medical device that received FDA 510(k) clearance on 2025-11-18. It is manufactured by Ulrich GmbH & Co. KG. The 510(k) number is K252281.

When was ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) approved by the FDA?

ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) received FDA 510(k) clearance on 2025-11-18, under approval number K252281.

What company makes ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)?

ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) is manufactured by Ulrich GmbH & Co. KG.

What is the FDA product code for ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)?

The FDA product code for ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) is IZQ.

Other Devices by Ulrich GmbH & Co. KG

K161032neon3™ universal OCT spinal stabilization K161723ulrich Transfer Set K171392ulrichINJECT CT motion K192117Small VBR™ K202227Artus™ cervical plate system K192872ulrichINJECT CT Motion

View all 11 devices →

Related Devices (Code: IZQ)

K151048CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient SetBracco Injeneering K152361OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base SystemLiebel-Flarsheim Company, LLC K171392ulrichINJECT CT motionUlrich GmbH & Co. KG K192872ulrichINJECT CT MotionUlrich GmbH & Co. KG K210541ulrichINJECT CT motionUlrich GmbH & Co. KG K241849MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)Imaxeon Pty, 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.

↑