What Masimo Corporation told the SEC could break it.

Approximately 91.2% of Masimo's U.S. pulse oximetry product sales flow through customers that are members of Group Purchasing Organizations; failure to renew GPO contracts (which can be strict sole-source/bundling) could cause significant loss of market share.

“Shipments of our pulse oximetry products to customers that are members of GPOs represent approximately 91.2% of our U.S. product sales. Our failure to renew our contracts with GPOs may cause us to lose market share and could have a material adverse effect on our business, financial condition and results of operations.”

One just-in-time healthcare distributor accounted for 18.8% of healthcare revenue in FY2025 (18.5% / 18.1% prior years); loss of this distributor would materially reduce net sales.

“For the years ended January 3, 2026, December 28, 2024 and December 30, 2023, the Company had sales through one just-in-time healthcare distributor that represented 18.8 %, 18.5 %, and 18.1 % of healthcare revenue, respectively.”

With production in the U.S., Mexico and Malaysia and raw materials imported from China (plus subassemblies from Malaysia and Mexico), 2025 U.S. tariffs raise raw-material and finished-goods costs; Masimo is pursuing USMCA exemptions and alternative China suppliers to mitigate.

“During the first quarter of 2025, the U.S. government imposed a series of tariffs on many products imported into the U.S. from China, Canada and Mexico. Since that time the U.S. government has increased some of those tariffs and postponed others. It has threatened to levy additional tariffs on some countries and new tariffs on additional countries, including those of the European Union, Asia and South America.”

2025 FDA layoffs of ~3,500 employees (≈19% of its workforce) raise concern over the agency's capacity for timely review and approval of Masimo's medical devices.

“In 2025, the FDA laid off approximately 3,500 employees, representing approximately 19% of its workforce at the beginning of the year. Such workforce reductions at the FDA have raised some concerns regarding the agency's capacity to perform timely regulatory reviews and approvals of medical devices.”

Masimo depends on sole or limited source suppliers for key components including digital signal processor chips and analog-to-digital converter chips; supply constraints would prevent product delivery.

“We depend on certain sole or limited source suppliers for certain key materials and components, including digital signal processor chips and analog-to-digital converter chips for certain products. These suppliers are located around the world, and the production and shipment of such materials and components may be constrained globally due to freight carrier delays and other disruptions to the supply chain.”