Cleared Traditional

K182618 - SleepImage System

K182618 is an FDA 510(k) clearance for SleepImage System, manufactured by Mycardio, LLC Dba Sleepimage.. The device is a Class 2 Anesthesiology device with product code MNR cleared through the Traditional 510(k) pathway after a 324-day FDA review.

K182618 · Mycardio, LLC Dba Sleepimage. · Anesthesiology device
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Aug 2019
Decision
324d
Days
Class 2
Risk

K182618 is an FDA 510(k) clearance for the SleepImage System. Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by Mycardio, LLC Dba Sleepimage. (Denver, US). The FDA issued a Cleared decision on August 14, 2019 after a review of 324 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2375 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Mycardio, LLC Dba Sleepimage. devices

FDA 510(k) Submission Details - K182618

510(k) Number K182618 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2018
Decision Date August 14, 2019
Days to Decision 324 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
184d slower than avg
Panel avg: 140d · This submission: 324d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNR Device Classification - Class 2, Special Controls

Product Code MNR Ventilatory Effort Recorder
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2375
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - MNR Ventilatory Effort Recorder

All 120
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