Sunny, a self-care brand in menstrual care, has achieved another milestone with their Sunny Cup + Applicator, now the first menstrual cup and applicator to receive FDA 510(k) clearance. This Class II Medical Device addresses the primary barrier preventing tampon users from switching to more sustainable menstrual products, free from potentially harmful materials.
Sunny is a queer, women, and BIPOC-owned self-care brand dedicated to sustainable period care, inclusive education, and global impact initiatives. Co-founder and CEO Cindy Belardo was inspired to address period poverty and promote eco-friendly alternatives after a research trip to India in 2018. Drew Jarvis, Co-founder and CMO, began her journey in period care innovation after experimenting with menstrual cups in high school. Her idea for a menstrual cup that inserts like a tampon won a business pitch competition during her senior year. The chance meeting between Belardo and Jarvis led to the birth of Sunny, merging their shared passion for menstrual health and self-care.
The Sunny Cup + Applicator, made from medical-grade silicone and other reusable medical-grade materials, functions similarly to a tampon in its insertion method but offers significantly greater capacity, holding 2-5 times more fluid and usable for up to 12 hours. Its reusable nature, lasting up to a year, makes it an environmentally friendly option in menstrual care.
“Menstrual cups have historically been exempt from the 510(k) process due to substantial equivalence,” said Drew Jarvis, founder and CMO of Sunny. “Because we invented the very first menstrual cup applicator, we had to kind of reprove that substantial equivalence, so we had to go through the 510(k) process, which speaks to the innovative nature of our device.”
The FDA clearance comes at a crucial time, given recent concerns about lead, heavy metals, and other toxic materials found in leading menstrual products. Sunny’s product provides a safe, more sustainable alternative, aligning with growing consumer awareness and demand for healthier period care options.
Since launching in 2022, Sunny has sold 20,000 units, raised $2.5 million, and secured $850,000 in presale orders. The brand has also gone viral on TikTok. With the recent FDA clearance, Sunny now aims to establish a sustainable manufacturing process to meet the high demand, with plans to fulfill outstanding pre-orders and re-open sales by the end of the year.
