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The Tracker / March 2026 / K253047

510(k) cleared

PRESSONE

Nipro Medical Corporation · Mar 24, 2026 · K253047

FDA cleared the PRESSONE from Nipro Medical Corporation on Mar 24, 2026 under K253047, a traditional 510(k). The device falls under product code FMI, Needle, Hypodermic, Single Lumen, regulated at 21 CFR 880.5570 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Sep 22, 2025. The decision came 183 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Nipro Medical Corporation has 2 other decisions in the tracker over the last 12 months: K261399 (ELISIO-HX), K260533 (ELISIO-H).

Questions & Answers

What did FDA clear under K253047?

K253047 is the FDA 510(k) for PRESSONE, submitted by Nipro Medical Corporation. FDA's decision date was Mar 24, 2026, under product code FMI (Needle, Hypodermic, Single Lumen).

Who makes the PRESSONE?

Nipro Medical Corporation, based in Miami, FL, is the applicant of record for K253047.

How long did the K253047 review take?

FDA received the submission on Sep 22, 2025 and issued its decision on Mar 24, 2026, 183 days later.

← All decisions in March 2026

Sources