The CADDIE device, intended for gastroenterology and urology applications, secured a Special 510(k) clearance, signaling substantial equivalence to a predicate device.
Odin Medical Limited has received Special 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its CADDIE device. The clearance, dated September 12, 2026, designates the CADDIE as substantially equivalent to a predicate device, allowing its marketing in the United States.
The CADDIE device falls under Product Code QNP and is classified as a Class II medical device. Its regulatory pathway involved an advisory committee meeting focused on Gastroenterology and Urology, indicating its intended use in these specialties. The specific functionalities or clinical indications of the CADDIE device beyond its general product code designation have not been publicly detailed at this time.
Regulatory Context of Special 510(k)
A Special 510(k) clearance typically applies to modifications of a manufacturer's own previously cleared device. This pathway is utilized when the modification does not affect the device's intended use or alter its fundamental scientific technology, and the changes can be verified by a review of design control activities. This differs from a Traditional 510(k), which is used for new devices or significant modifications to devices where a new predicate is necessary.
For Odin Medical, the Special 510(k) designation implies that the CADDIE device represents an iteration or modification of an earlier product already cleared by the FDA. The agency determined that the changes introduced in the CADDIE device did not raise new questions of safety or effectiveness, allowing for an expedited review process compared to other 510(k) pathways.
The FDA's decision of 'Substantially Equivalent' means the device is as safe and effective as a legally marketed predicate device, without requiring new clinical trials to demonstrate efficacy for novel claims.
Device Classification and Future Implications
As a Class II device under regulation number 876.1520, the CADDIE will be subject to general controls, including quality system regulations, labeling requirements, and premarket notification. Specific special controls for devices within this classification typically address performance standards, post-market surveillance, and particular testing requirements to assure safety and effectiveness.
The product code QNP and the involvement of the Gastroenterology and Urology advisory committee suggest the CADDIE device likely pertains to diagnostic or therapeutic applications within these areas. Further details regarding the CADDIE's specific features, operational mechanism, and target patient population are not yet publicly disclosed by Odin Medical. The market entry strategy, commercial availability, and pricing information for the CADDIE device remain to be announced by the company.
