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SpiderView

by Ela Medical, Inc.

510(k) K032466

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 · Special NumberK032466 Date22 Aug 2003ClearedStatusActive

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  • Withdrawn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
MWJ
Device Class
Class II
Regulation
21 CFR Part 870.2800
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

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

SpiderView is an ambulatory electrocardiograph without analysis, classified as a Class II medical device under FDA regulation 870.2800. It is designed to record and play back physiological signals from amplifiers, signal conditioners, or computers, functioning as a magnetic tape recorder for cardiovascular monitoring applications.

SpiderView received FDA 510(k) clearance (K032466) on August 22, 2003, and is manufactured by Ela Medical, Inc. in Plymouth, Minnesota. The device is supplied as a reusable system for clinical use in cardiovascular settings, with no indication of sterility, single-use designation, or MRI safety provided in the data.

Other devices from Ela Medical, Inc.

See all devices from Ela Medical, Inc. →

Questions

AI-generated answers, 6 Oct 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 SpiderView device used for?

    SpiderView is an ambulatory electrocardiograph without analysis that records and plays back physiological signals from amplifiers, signal conditioners, or computers for cardiovascular monitoring applications.

  • Is the SpiderView device single-use or reusable?

    The SpiderView is supplied as a reusable system for clinical use in cardiovascular settings, as there is no indication of single-use designation in the provided data.

  • What regulatory status does the SpiderView have?

    SpiderView received FDA 510(k) clearance (K032466) on August 22, 2003, and is classified as a Class II medical device under FDA regulation 870.2800.

  • Is the SpiderView device supplied sterile?

    There is no indication of sterility provided in the device data for the SpiderView system.