The clearance of this Class II device suggests a focus on mitigating needlestick injuries for healthcare professionals, leveraging a traditional 510(k) pathway for market entry.
CMT Health PTE., Ltd. has secured 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Profoject™ Safety Sliding Blood Collection Set. The device, classified as Class II, received a Substantially Equivalent decision on September 25, 2026, indicating its comparability to existing predicate devices on the market.
The Profoject™ set falls under product code JKA, which is associated with blood specimen collection devices, and was reviewed by the Clinical Chemistry advisory committee. This traditional 510(k) clearance allows CMT Health to market the device in the U.S.
Device Design and Safety Implications
The Profoject™ Safety Sliding Blood Collection Set is designed to facilitate the safe collection of blood samples. The term "Safety Sliding" in its name suggests features intended to protect healthcare workers from accidental needlestick injuries, a persistent concern in clinical settings. Such features typically involve passive or active mechanisms to cover or retract the needle immediately after use.
Needlestick injuries carry risks of transmitting bloodborne pathogens, posing a significant occupational hazard. Devices incorporating safety mechanisms are crucial for mitigating these risks, contributing to a safer environment for medical personnel. While specific design details and performance data for the Profoject™ device beyond its regulatory classification are not publicly detailed in the clearance summary, its designation as a "Safety" device underscores its intended protective function.
"The consistent introduction of safety-engineered medical devices reflects an ongoing effort to address occupational hazards in healthcare, aligning with broader public health objectives."
Regulatory Pathway and Market Positioning
The traditional 510(k) pathway used by CMT Health for the Profoject™ set confirms that the FDA found it substantially equivalent to a legally marketed predicate device. This process typically involves demonstrating that the new device is as safe and effective as the predicate and does not raise new questions of safety or effectiveness.
CMT Health PTE., Ltd. has not yet disclosed specific commercial launch plans, pricing, or further clinical data supporting the Profoject™ Safety Sliding Blood Collection Set. The clearance positions the company to enter a competitive market segment for blood collection devices, where safety features are increasingly becoming a standard expectation.
