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Apollo is in talks to buy J&J's DePuy Synthes for close to $20B BRAINBox signs Prolight to supply the readers for its concussion blood test Intuitive wins a CE mark for transvaginal surgery with the da Vinci SP Beta Bionics clears the Mint patch pump and cuts 2026 guidance the same day J&J sells the Laminar LAA program it bought for $400M upfront in 2023 GE HealthCare is in talks to buy Sofie Biosciences for about $1B Implicity raises $40M to run cardiac implant monitoring across four vendors Boston Scientific says plants and shipping are fully back 17 days after the cyberattack FDA seeks comment on device tracking and raises the burden estimate by 47,526 hours Apollo is in talks to buy J&J's DePuy Synthes for close to $20B BRAINBox signs Prolight to supply the readers for its concussion blood test Intuitive wins a CE mark for transvaginal surgery with the da Vinci SP Beta Bionics clears the Mint patch pump and cuts 2026 guidance the same day J&J sells the Laminar LAA program it bought for $400M upfront in 2023 GE HealthCare is in talks to buy Sofie Biosciences for about $1B Implicity raises $40M to run cardiac implant monitoring across four vendors Boston Scientific says plants and shipping are fully back 17 days after the cyberattack FDA seeks comment on device tracking and raises the burden estimate by 47,526 hours

The Tracker / September 2026 / K260331

510(k) cleared

IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13)

Siemens Healthcare Diagnostics Products, Ltd. · Sep 4, 2026 · K260331

FDA cleared the IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13) from Siemens Healthcare Diagnostics Products, Ltd. on Sep 4, 2026 under K260331, a traditional 510(k). The device falls under product code DHB, System, Test, Radioallergosorbent (Rast) Immunological, regulated at 21 CFR 866.5750 as a Class 2 device. The review panel was Immunology.

FDA logged the submission as received on Feb 2, 2026. The decision came 214 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Siemens Healthcare Diagnostics Products, Ltd. has 8 other decisions in the tracker over the last 12 months: K253985 (INNOVANCE® D-Dimer 2.0 (SMN 10873803)), K253528 (Atellica IM CA 19-9 II), K261364 (Atellica CH Acetaminophen 2 (ACTM)), K253264 (myAblation Guide (VC10A)).

Questions & Answers

What did FDA clear under K260331?

K260331 is the FDA 510(k) for IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13), submitted by Siemens Healthcare Diagnostics Products, Ltd.. FDA's decision date was Sep 4, 2026, under product code DHB (System, Test, Radioallergosorbent (Rast) Immunological).

Who makes the IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13)?

Siemens Healthcare Diagnostics Products, Ltd., based in Llanberis, is the applicant of record for K260331.

How long did the K260331 review take?

FDA received the submission on Feb 2, 2026 and issued its decision on Sep 4, 2026, 214 days later.

← All decisions in September 2026