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FDA opens a comment docket on the device regulatory science gaps of the next decade FDA makes the Boston Scientific Imager II removal a Class I recall Labs push the RESULTS Act after CMS cuts 775 test codes by the full 15 percent Boston Scientific clears SpaceOAR Flex, a rectal spacer the physician can stop mid-injection Shockwave founder Daniel Hawkins takes the board chair at Solenic Medical NeuroSigma takes its ADHD nerve stimulator into psychiatry clinics through Firefly's EEG network Intuitive wins a CE mark for adult cardiac surgery with da Vinci 5 Forj Medical opens a Costa Rica plant with ISO Class 8 cleanrooms and 50 staff Marani Health clears the M•care system for fetal and maternal monitoring at home FDA opens a comment docket on the device regulatory science gaps of the next decade FDA makes the Boston Scientific Imager II removal a Class I recall Labs push the RESULTS Act after CMS cuts 775 test codes by the full 15 percent Boston Scientific clears SpaceOAR Flex, a rectal spacer the physician can stop mid-injection Shockwave founder Daniel Hawkins takes the board chair at Solenic Medical NeuroSigma takes its ADHD nerve stimulator into psychiatry clinics through Firefly's EEG network Intuitive wins a CE mark for adult cardiac surgery with da Vinci 5 Forj Medical opens a Costa Rica plant with ISO Class 8 cleanrooms and 50 staff Marani Health clears the M•care system for fetal and maternal monitoring at home

The Tracker / September 2026 / K262163

510(k) cleared

BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton Broth

Becton Dickinson and Company · Sep 14, 2026 · K262163

FDA cleared the BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton Broth from Becton Dickinson and Company on Sep 14, 2026 under K262163, a traditional 510(k). The device falls under product code JTZ, Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth, regulated at 21 CFR 866.1700 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on Jun 26, 2026. The decision came 80 days later, inside the 90 FDA-day goal for a 510(k).

Becton Dickinson and Company has 8 other decisions in the tracker over the last 12 months: K260128 (BD Preset and BD A-Line Arterial Blood Collection Syringes), K252378 (BD® MiniDraw Capillary Blood Collection System with BD® MiniDraw SST Capillary Blood Collection Tube), K252506 (BD Vacutainer® Safety-Lok Blood Collection Set; BD Vacutainer® Safety-Lok Blood Collection Set with Pre-Attached Holder), K252137 (BD Insyte IV Catheter).

Questions & Answers

What did FDA clear under K262163?

K262163 is the FDA 510(k) for BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton Broth, submitted by Becton Dickinson and Company. FDA's decision date was Sep 14, 2026, under product code JTZ (Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth).

Who makes the BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton Broth?

Becton Dickinson and Company, based in Sparks, MD, is the applicant of record for K262163.

How long did the K262163 review take?

FDA received the submission on Jun 26, 2026 and issued its decision on Sep 14, 2026, 80 days later.

← All decisions in September 2026