Skip to content

Touch Flush Continuous Fast/Flush

by Norton Performance Plastics Corp.

510(k) K820677

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK820677 Date25 Mar 1982ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DRS
Device Class
Class II
Regulation
21 CFR Part 870.2850
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The device is a Transducer, Blood-Pressure, Extravascular, as defined in the device name and openFDA data. It is classified as a Class II medical device under regulation number 870.2850 and product code DRS.

It received FDA 510(k) clearance (K820677) on March 25, 1982, with a traditional submission and SESE decision. The device is manufactured by Norton Performance Plastics Corp. in McHenry, Illinois, and is intended for cardiovascular applications per the advisory committee classification.

Other devices from Norton Performance Plastics Corp.

See all devices from Norton Performance Plastics Corp. →

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • 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.