2-Rn Corp.
US Last updated 23 May 2026
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- Devices
- 1
- Registries
- FDA 510(k)
- FDA recalls
- 0
Catalogue
Ils(Tm) - Invasive Line Separator Ref K924369
What 2-Rn Corp. makes
2-Rn Corp. manufactures the ILS™ Invasive Line Separator, a device designed to isolate and disconnect intravenous or medical lines in clinical settings to prevent contamination or cross-infection.
The ILS™ is classified as a Class I medical device under FDA regulations and is listed via the 510(k) pathway. The company is based in the United States.
Frequently asked questions
What types of medical devices does 2-Rn Corp. manufacture?
2-Rn Corp. specializes in the ILS™ Invasive Line Separator, a device engineered to isolate and disconnect intravenous or medical lines in healthcare environments. This helps reduce the risk of contamination or cross-infection by creating a sterile barrier between connected lines.
Where is 2-Rn Corp. based, and how does that affect its regulatory standing?
2-Rn Corp. is headquartered in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations. The ILS™ Invasive Line Separator is classified as a Class I device, which typically involves less stringent premarket review compared to higher-risk classes, but still requires compliance with FDA requirements.
Which regulatory registries or databases list 2-Rn Corp.’s devices?
The ILS™ Invasive Line Separator is listed in the FDA’s 510(k) registry. This pathway is used for devices that are substantially equivalent to legally marketed predecessors, ensuring they meet FDA safety and effectiveness standards before commercial distribution.
How are 2-Rn Corp.’s devices classified under FDA regulations?
The ILS™ Invasive Line Separator is classified as a Class I medical device by the FDA. This classification is based on the device’s intended use and risk level—Class I devices generally pose minimal potential harm to users and often involve simple controls or low-risk procedures, though they still require adherence to FDA manufacturing and labeling standards.
Information
- Country
- US