Cleared Traditional

K222950 - AcuPebble OX100

K222950 is an FDA 510(k) clearance for AcuPebble OX100, manufactured by Acurable Limited. The device is a Class 2 Anesthesiology device with product code MNR cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K222950 · Acurable Limited · Anesthesiology device
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Feb 2023
Decision
129d
Days
Class 2
Risk

K222950 is an FDA 510(k) clearance for the AcuPebble OX100. Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by Acurable Limited (London, GB). The FDA issued a Cleared decision on February 3, 2023 after a review of 129 days - within the typical 510(k) review window.

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 Acurable Limited devices

FDA 510(k) Submission Details - K222950

510(k) Number K222950 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2022
Decision Date February 03, 2023
Days to Decision 129 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
11d faster than avg
Panel avg: 140d · This submission: 129d
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 K222950.
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WatchPAT ONE (WP1)
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K222331 · Itamar Medical , Ltd. · Sep 2022