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# Cardio Device Status Indicators Not 510(k) Exempt
- URL: https://www.fdaweb.com/cardio-device-status-indicators-not-510-k-exempt/
- Published: 2017-10-10T12:00:00.000Z
- Updated: 2026-09-14T22:55:03.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5139825

*Federal Register* correction: FDA is correcting a final order entitled “Medical Devices; Cardiovascular Devices; Classification of the Adjunctive Cardiovascular Status Indicator” that appeared in the 7/28 *Federal Register*. The order was published with an incorrect statement in the preamble about whether FDA planned to exempt the device from premarket notification requirements. This document corrects that error and indicates that for this type of device FDA has determined premarket notification is necessary to provide reasonable assurance of safety and effectiveness. Therefore, this device type is not exempt from premarket notification requirements. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-10-10/pdf/2017-21659.pdf?ref=fdaweb.com).