Biosensors Central Venous Catheter Kits

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K002786 ↗

FDA Product Code

FOZ

Device Class

Class II

Regulation

21 CFR Part 880.5200

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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• Heparin Coated Thermodilution Cath & Accessories

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• Biotrans Reusable Sensor Base Model Number Bt Xxxxxx

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• Biosensors Embolectomy Catheter

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• Safewedge(Tm) Relief Valve Device

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  FDA 510(k) K912172 Active Cleared 27 Sep 1991

• Biotrans Pressure Monitoring Kit Model Number Bt Xxxxxx

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  FDA 510(k) K981747 Active Cleared 20 Aug 1998

• Are these catheter kits designed for long-term use, or are they specifically meant for short-term central venous access (less than 30 days)?

  These Biosensors Central Venous Catheter Kits are explicitly designed for short-term therapeutic use only, defined as less than 30 days. The FDA’s classification (Catheter, Intravascular, Therapeutic, Short-term) and the product’s intended clinical setting—general hospitals—reflect this limitation. They are not approved for prolonged or long-term venous access.

• How are the Biosensors Central Venous Catheter Kits supplied, and what does the sterile packaging ensure?

  Each kit is supplied sterile and intended for single-use in clinical environments like general hospitals. The sterile packaging ensures that all components—including the central venous catheter and biosensors—are free from contamination before use, reducing infection risk during short-term central venous procedures.

• What types of physiological parameters can the biosensors in these kits monitor, and how does that differ from standard central venous catheters?

  While the exact physiological parameters monitored by the biosensors aren’t detailed in the provided data, the kits are specifically designed to integrate biosensors for real-time monitoring alongside intravenous administration or blood sampling. This distinguishes them from standard central venous catheters by adding functional capabilities for tracking vital signs or other clinical metrics during short-term use.

• Are these kits reusable, or must they be discarded after a single procedure?

  The kits are explicitly intended for single-use only, as stated in the manufacturer’s description. This aligns with best practices for minimizing infection risk in central venous access procedures, particularly in hospital settings where sterility and patient safety are critical.

• What regulatory pathway did Sunscope Intl., Inc. follow to obtain clearance for these kits, and what does the FDA’s decision mean for their use?

  Sunscope Intl., Inc. pursued a traditional 510(k) pathway (K002786) to demonstrate that their Biosensors Central Venous Catheter Kits are substantially equivalent to a legally marketed predicate device. The FDA’s clearance under Product Code FOZ (Catheter, Intravascular, Therapeutic) confirms compliance with U.S. standards for short-term intravascular use, allowing clinical use in general hospitals as intended.