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Holter Cura-Lite Recorder

by Cardionostics, Inc.

510(k) K844977

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 NumberK844977 Date14 Jan 1985ClearedStatusActive

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  • Withdrawn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
DSH
Device Class
Class II
Regulation
21 CFR Part 870.2800
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 Holter Cura-Lite Recorder is a medical device classified as a Recorder, Magnetic Tape, Medical, designed to record and store physiological signals such as ECG waveforms on magnetic tape. It is intended for continuous ambulatory monitoring of cardiac activity over extended periods, providing diagnostic data for cardiovascular assessment.

This device is supplied as a reusable medical instrument and is regulated under FDA 510(k) clearance (K844977) with a classification of Class II (DSH). It is intended for clinical use in cardiovascular settings and requires proper maintenance and calibration to ensure accurate recording. The device was authorized in 1985 and remains subject to FDA oversight as a substantially equivalent cardiovascular recording system.

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