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The Tracker / September 2026 / K262532

510(k) cleared

NORMOFLO Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61)

ICU Medical · Sep 18, 2026 · K262532

FDA cleared the NORMOFLO Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61) from ICU Medical on Sep 18, 2026 under K262532, a traditional 510(k). The device falls under product code LGZ, Warmer, Thermal, Infusion Fluid, regulated at 21 CFR 880.5725 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Jul 22, 2026. The decision came 58 days later, inside the 90 FDA-day goal for a 510(k).

ICU Medical has 3 other decisions in the tracker over the last 12 months: K252130 (LifeShield Infusion Safety Software Suite), K252006 (OTTO Disinfecting Cap), K251980 (ClaveQS Bag).

Questions & Answers

What did FDA clear under K262532?

K262532 is the FDA 510(k) for NORMOFLO Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61), submitted by ICU Medical. FDA's decision date was Sep 18, 2026, under product code LGZ (Warmer, Thermal, Infusion Fluid).

Who makes the NORMOFLO Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61)?

ICU Medical, based in Lake Forest, IL, is the applicant of record for K262532.

How long did the K262532 review take?

FDA received the submission on Jul 22, 2026 and issued its decision on Sep 18, 2026, 58 days later.

← All decisions in September 2026

Sources