Cleared Traditional

K221816 - Wesper Lab

K221816 is an FDA 510(k) clearance for Wesper Lab, manufactured by Wesper, Inc.. The device is a Class 2 Anesthesiology device with product code MNR cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K221816 · Wesper, Inc. · Anesthesiology device
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Mar 2023
Decision
260d
Days
Class 2
Risk

K221816 is an FDA 510(k) clearance for the Wesper Lab. Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by Wesper, Inc. (New York, US). The FDA issued a Cleared decision on March 9, 2023 after a review of 260 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 Wesper, Inc. devices

FDA 510(k) Submission Details - K221816

510(k) Number K221816 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2022
Decision Date March 09, 2023
Days to Decision 260 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
120d slower than avg
Panel avg: 140d · This submission: 260d
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
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