FDA applicant

Mycardio, LLC Dba Sleepimage.

Broomfield, CO2 decisions2017–20190 recalls

FDA records 2 decisions for Mycardio, LLC Dba Sleepimage. (Broomfield, CO) from 2017 to 2019: 2 510(k) clearances. All are in product code MNR (Ventilatory Effort Recorder). Its devices cite 2 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, anesthesiology panel, where it files most

How often FDA has decided Mycardio, LLC Dba Sleepimage.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Mycardio, LLC Dba Sleepimage. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Mycardio, LLC Dba Sleepimage.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Mycardio”

FDA records each applicant name separately; these may or may not be the same firm.

MyCardio, LLC 1

Mycardio, LLC Dba Sleepimage.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Mycardio”