Cleared Traditional

K213360 - SleepCheckRx

K213360 is an FDA 510(k) clearance for SleepCheckRx, manufactured by Resapp Health. The device is a Class 2 Anesthesiology device with product code MNR cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K213360 · Resapp Health · Anesthesiology device
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Jul 2022
Decision
266d
Days
Class 2
Risk

K213360 is an FDA 510(k) clearance for the SleepCheckRx. Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by Resapp Health (Brisbane, AU). The FDA issued a Cleared decision on July 5, 2022 after a review of 266 days - an extended review cycle.

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. Standard predicate reliance. 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 Resapp Health devices

FDA 510(k) Submission Details - K213360

510(k) Number K213360 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 2021
Decision Date July 05, 2022
Days to Decision 266 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
126d slower than avg
Panel avg: 140d · This submission: 266d
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 64
Devices cleared under the same product code (MNR) and FDA review panel - the closest regulatory comparables to K213360.
BresoDX1
K220012 · Bresotec, Inc. · Dec 2022
WatchPAT300 (WP300)
K222331 · Itamar Medical , Ltd. · Sep 2022
ANNE Sleep
K220095 · Sibel, Inc. · Jul 2022
Onera Sleep Test System (Onera STS)
K210593 · Onera B.V. · Apr 2022
WatchPAT200U (WP200U)
K203839 · Itamar Medical , Ltd. · Mar 2022
NightOwl
K220028 · Ectosense NV · Feb 2022