Touch Flush Continuous Fast/Flush

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

510(k) Number

K820677 ↗

FDA Product Code

DRS

Device Class

Class II

Regulation

21 CFR Part 870.2850

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K820864 Active Cleared 15 Apr 1982

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See all devices from Norton Performance Plastics Corp. →

• What is the Touch Flush Continuous Fast/Flush device used for?

  The device is a blood-pressure transducer designed for extravascular use, intended to measure blood pressure in cardiovascular applications as indicated by its classification and advisory committee assignment to the cardiovascular medical specialty.

• Who manufactures the Touch Flush Continuous Fast/Flush device and where is it made?

  The device is manufactured by Norton Performance Plastics Corp. at their facility located at 803 N. Front St. Suite 3, McHenry, Illinois, 60050, United States.

• What regulatory pathway was used for the Touch Flush Continuous Fast/Flush device?

  The device received FDA 510(k) clearance through a traditional submission process, with the clearance number K820677 granted on March 25, 1982, based on a determination of substantial equivalence.

• What is the product code and regulation number for the Touch Flush Continuous Fast/Flush device?

  The device is assigned product code DRS and is regulated under 21 CFR 870.2850, which governs extravascular blood-pressure transducers as a Class II medical device.

• Is the Touch Flush Continuous Fast/Flush device a Class II medical device?

  Yes, the device is classified as a Class II medical device under FDA regulation number 870.2850, as confirmed by the openFDA data and device classification details provided in the authorization record.