Cleared Traditional

K220012 - BresoDX1

K220012 is an FDA 510(k) clearance for BresoDX1, manufactured by Bresotec, Inc.. The device is a Class 2 Anesthesiology device with product code MNR cleared through the Traditional 510(k) pathway after a 351-day FDA review.

K220012 · Bresotec, Inc. · Anesthesiology device
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Dec 2022
Decision
351d
Days
Class 2
Risk

K220012 is an FDA 510(k) clearance for the BresoDX1. Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by Bresotec, Inc. (Toronto, CA). The FDA issued a Cleared decision on December 21, 2022 after a review of 351 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Bresotec, Inc. devices

FDA 510(k) Submission Details - K220012

510(k) Number K220012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 2022
Decision Date December 21, 2022
Days to Decision 351 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
211d slower than avg
Panel avg: 140d · This submission: 351d
Pathway characteristics
Predicate-based equivalence.

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

Regulatory Peers - MNR Ventilatory Effort Recorder

All 62
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