Cleared Traditional

K222579 - Belun Sleep System BLS-100

K222579 is an FDA 510(k) clearance for Belun Sleep System BLS-100, manufactured by Belun Technology Company Limited. The device is a Class 2 Anesthesiology device with product code MNR cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K222579 · Belun Technology Company Limited · Anesthesiology device
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Feb 2023
Decision
182d
Days
Class 2
Risk

K222579 is an FDA 510(k) clearance for the Belun Sleep System BLS-100. Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by Belun Technology Company Limited (Sha Tin, CN). The FDA issued a Cleared decision on February 23, 2023 after a review of 182 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 Belun Technology Company Limited devices

FDA 510(k) Submission Details - K222579

510(k) Number K222579 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2022
Decision Date February 23, 2023
Days to Decision 182 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 140d · This submission: 182d
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 62
Devices cleared under the same product code (MNR) and FDA review panel - the closest regulatory comparables to K222579.
Somfit
K231546 · Compumedics Limited · Nov 2023
Onera Sleep Test System (Onera STS)
K223573 · Onera B.V. · Aug 2023
Wesper Lab
K221816 · Wesper, Inc. · Mar 2023
AcuPebble OX100
K222950 · Acurable Limited · Feb 2023
WatchPAT ONE (WP1)
K223675 · Itamar Medical , Ltd. · Jan 2023
BresoDX1
K220012 · Bresotec, Inc. · Dec 2022