Carr Tech Corp Celebrates FDA 510(k) Class II Approval of FROG All-in-One Filter Needle

This transformative device advances safety and efficiency in drug preparation, underscoring the startup's journey from solo founder to FDA-cleared innovator.

FREDERICK, Md., April 25, 2025 /PRNewswire/ -- Carr Tech Corp, a Maryland-based medical device startup founded by pharmacist-turned-entrepreneur Sue Carr, proudly announces that the company has received FDA 510(k) Class II clearance for its flagship product, FROG (Filter Removal of Glass), an all-in-one filter needle designed to enhance safety and efficiency in medication preparation and administration.

"I am humbly grateful and happy to announce that we officially received FDA 510(k) Class II approval of FROG," said Carr. "This milestone is not just a win for Carr Tech—it's a win for every healthcare worker who's ever struggled with cumbersome drug prep protocols and every patient who deserves safer medication handling."

FROG is the first and only all-in-one filter needle that eliminates multiple steps from the current multi-component method of drawing medication from glass ampoules. Traditional procedures often involve using separate filter and non-filter needles to prevent the risk of glass particle contamination—a process that is time-consuming, costly, and prone to error. FROG's innovative design consolidates these steps, reducing procedural risk, streamlining workflow, and enhancing patient safety.

510(k) Class II approval is a rigorous regulatory hurdle that signifies a product is "substantially equivalent" in safety and effectiveness to a legally marketed device. For startups, it represents a critical gatekeeper to commercialization—one that only a fraction of emerging businesses successfully pass. According to industry data, fewer than 12% of medical device startups reach FDA clearance. The average cost to bring a new device to market can exceed $30 million and take up to a decade, not including the investment needed to sustain a business until profitability.

Carr, who started Carr Tech as a one-person operation driven by her experiences in hospital pharmacies, credits her team and ecosystem of supporters for the achievement. "Thank you to the Carr Tech team, our incredible supporters, Gilero (a Sanner Group company), Kymanox, TEDCO, Old Line Capital Partners, and especially FITCI for being our home base and springboard," she said. "Thank you for believing in me throughout the journey."

Carr Tech's success highlights the critical role of business incubators like the Frederick Innovative Technology Center, Inc. (FITCI), which supported Carr Tech through mentorship, work/lab space, a support community, and connections to funding resources and commercialization partners.

"This is a momentous achievement," said Kathie Callahan Brady, CEO of FITCI. "FDA approval is one of the most difficult and resource-intensive barriers for startups in the life sciences. Most companies never make it this far. That's what makes this moment so meaningful—for Carr Tech, for Frederick, and for every aspiring innovator. It proves that with the right support and extraordinary determination, even a small team can overcome big hurdles and change lives."

Carr's inspiration for FROG stemmed from years spent witnessing the impact of filter failure in hospital emergency settings. Her concern was that injections contaminated with microscopic glass shards could lead to preventable complications. Determined to find a solution, she leveraged her pharmaceutical background to design a single-use, easy-to-use device that minimizes the risk of error and improves compliance with safety protocols.

The FDA clearance marks a turning point for Carr Tech. With the green light to begin full-scale production and sales, the company is positioned to bring this safer alternative to hospitals, surgical centers, and clinics nationwide, ending outdated ampoule-handling procedures. Plans for manufacturing scale-up and expanded distribution are already underway – even on a global scale.

"This approval allows us to take the next step in our mission to revolutionize medication safety," said Carr. "We're just getting started."

For more information about Carr Tech Corp or the FROG device, visit www.carrtechcorp.com.

About Carr Tech Corp
Founded by Sue Carr, Carr Tech Corp is a Maryland-based medical device company focused on innovating safer, smarter solutions for medication delivery. The company's flagship product, FROG, is the first all-in-one filter needle designed to reduce glass particulate contamination and improve workflow in clinical settings.

About FITCI
The Frederick Innovative Technology Center, Inc. (FITCI) is a nonprofit incubator and accelerator that empowers science and technology startups through coaching, capital, and connections. Since 2004, FITCI has been a launchpad for local entrepreneurs building high-impact companies in Maryland's BioHealth Capital Region. Learn more at www.fitci.org.

Medicines packaged in glass ampoules include:

Vitamin K (administered to all newborns)

Morphine

Epinephrine

Narcan

Lidocaine

Fentanyl

Propofol

SOURCE Carr Tech Corp