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Motionspect

by Baltimore Therapeutic Equipment Co.

510(k) K895881

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK895881 Date10 Apr 1990ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
LXW
Device Class
Class III
Advisory Committee
Unknown
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 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 Motionspect is a Column, Adsorption, Low Density, Lipoprotein device, designed for the separation and analysis of lipoprotein fractions in blood samples. It employs adsorption chromatography to isolate and quantify different lipoprotein densities, aiding in cardiovascular risk assessment and diagnostic evaluation.

This device is supplied as a reusable column system intended for use in clinical or research laboratory settings. Sterility is not specified, and its use requires adherence to standard laboratory protocols for sample preparation and handling. The device is classified as Class III under FDA regulations and holds a Traditional 510K clearance (K895881) for marketing in the United States.

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