Cleared Traditional

K210480 - AcuPebble SA (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence.

K210480 · Acurable Limited · Anesthesiology device
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Jul 2021
Decision
137d
Days
Class 2
Risk

K210480 is an FDA 510(k) clearance for the AcuPebble SA. 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 July 6, 2021 after a review of 137 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

Submission Details

510(k) Number K210480 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2021
Decision Date July 06, 2021
Days to Decision 137 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
2d faster than avg
Panel avg: 139d · This submission: 137d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Anesthesiology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT03544086 Completed Observational Industry-sponsored

Clinical Evaluation of a Wearable Sleep Diagnosis Technology

150
Patients (actual)
1
Site
Condition studied Obstructive Sleep Apnea
Eligibility All sexes · 18 Years+
Principal investigator Dr Swapna Mandal, BSc MBBS MRCP SCE, PhD
Sponsor Acurable Ltd. (industry)
Started 2018-07-10 → Primary completion 2019-12-30 → Completed 2020-09-15
Primary outcome
Sensitivities and Specificities for diagnosis of sleep apnoea studies
Study completed - no results published. This trial concluded in 2020 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished. Individual participant data will not be shared.
View full study on ClinicalTrials.gov