Hypotrans Model 750

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K911577 ↗

FDA Product Code

KDK

Device Class

Class II

Regulation

21 CFR Part 876.5880

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Is the Hypotrans Model 750 designed for single-use or can it be reused after cleaning and sterilization?

  The Hypotrans Model 750 is explicitly supplied as a reusable device, meaning it is intended to be cleaned, sterilized, and reused for multiple transport and preservation cycles of kidneys. Since it is classified under FDA regulation 876.5880 and cleared via a 510(k) pathway, its reuse must comply with established medical device reprocessing protocols to maintain sterility and functionality.

• What types of clinical settings is the Hypotrans Model 750 approved for use in, and how does that relate to kidney transport?

  The Hypotrans Model 750 is intended for use in both gastroenterology and urology settings, though its primary function is the sterile transport and preservation of kidneys between clinical facilities. While the advisory committee classification includes gastroenterology, the device’s actual clinical application is strictly tied to kidney handling—ensuring viability during transit, not general organ preservation or unrelated procedures.

• How is the Hypotrans Model 750 regulated, and what does its 1992 clearance mean for current compliance?

  The Hypotrans Model 750 received FDA 510(k) clearance (K911577) in 1992 under the ‘substantially equivalent’ (SESE) determination, meaning it was deemed comparable to a legally marketed predicate device at the time. While the clearance predates modern regulatory frameworks, it remains valid for compliance—users must follow the original sterile transport protocols and reprocessing guidelines outlined in the device’s labeling and FDA clearance documentation to ensure ongoing safety and efficacy.

• Are there specific storage requirements for the Hypotrans Model 750, particularly regarding sterility or environmental conditions?

  The Hypotrans Model 750 is designed for use in controlled environments where sterile conditions are maintained, as required for organ transport. While the data does not specify exact storage temperatures or humidity controls, its reusable nature implies it must be properly cleaned, sterilized, and stored per manufacturer instructions to prevent contamination between uses. Adherence to standard medical device reprocessing protocols is critical to preserving sterility and functionality.