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Sensatrace

by Ludlow Corp., Technical Papers Division

510(k) K904185

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 NumberK904185 Date31 Oct 1990ClearedStatusActive

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  • Withdrawn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
DRX
Device Class
Class II
Regulation
21 CFR Part 870.2360
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

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

Sensatrace is a cardiovascular device classified under product code DRX. It is a substantially equivalent device that received FDA 510(k) clearance on October 31, 1990. The device was submitted by Ludlow Corp., Technical Papers Division and reviewed by the Cardiovascular advisory committee.

Sensatrace is supplied by Ludlow Corp., Technical Papers Division located in Chicopee, MA. The device is regulated under FDA 510(k) clearance with K number K904185. No information regarding sterility, single-use or reusable status, MRI safety, sizes, or storage conditions is provided in the device data.

Questions

AI-generated answers, 26 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 SENSATRACE used for?

    SENSATRACE is a cardiovascular device classified under product code DRX. It is a substantially equivalent device that received FDA 510(k) clearance on October 31, 1990, and was reviewed by the Cardiovascular advisory committee.

  • Who manufactures SENSATRACE and where is it supplied from?

    SENSATRACE is manufactured and supplied by Ludlow Corp., Technical Papers Division, located in Chicopee, MA. The company serves as the applicant for this device with FDA clearance number K904185.

  • What is the regulatory status of SENSATRACE?

    SENSATRACE is regulated under FDA 510(k) clearance with K number K904185. It was classified as substantially equivalent and received traditional clearance on October 31, 1990, after review by the Cardiovascular advisory committee.

  • Is information available about sterility, single-use status, or storage conditions for SENSATRACE?

    No information regarding sterility, single-use or reusable status, MRI safety, sizes, or storage conditions is provided in the device data for SENSATRACE.