Fast Formalert

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

510(k) Number

K853555 ↗

FDA Product Code

KOC

Device Class

Class II

Regulation

21 CFR Part 876.5820

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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See all devices from Organon Teknika Corp. →

• What is the Fast Formalert designed to monitor and how does it ensure patient safety during hemodialysis?

  The Fast Formalert is a reusable device designed specifically to monitor and alert for formaldehyde contamination in hemodialysis circuits. It functions as a real-time detection system, ensuring patient safety by identifying hazardous formaldehyde levels during dialysis procedures. This proactive monitoring helps prevent exposure to potentially harmful substances, which could otherwise compromise patient well-being.

• Is the Fast Formalert a single-use or reusable device, and what maintenance does it require?

  The Fast Formalert is a reusable device, meaning it can be used multiple times across different hemodialysis procedures. However, it requires proper calibration and maintenance as outlined in its operational instructions to ensure accurate formaldehyde detection. Regular upkeep is essential to sustain its performance and reliability in monitoring dialysis circuits.

• What regulatory pathway does the Fast Formalert follow, and what standards does it comply with?

  The Fast Formalert follows the FDA 510(k) clearance pathway, with the clearance number K853555. It is classified under 21 CFR 876.5820, adhering to strict medical device standards for hemodialysis accessories. This regulatory route ensures the device meets safety and effectiveness requirements for use in clinical settings.

• How does the Fast Formalert integrate into a hemodialysis setup, and what type of environment is it intended for?

  The Fast Formalert is designed as an accessory for hemodialysis circuits, functioning alongside existing equipment to provide real-time formaldehyde monitoring. It is intended exclusively for use in hemodialysis settings, where it helps maintain patient safety by detecting contamination risks during treatment. Its integration ensures seamless operation within the dialysis workflow.