Cleared Traditional

K173793 - XactTrace Single Use Respiratory Effort...

K173793 is the FDA 510(k) clearance for XactTrace Single Use Respiratory Effort... by Embla Systems. It is a Class 2 Anesthesiology device (product code MNR) cleared through the Traditional 510(k) pathway after a 442-day FDA review.

K173793 · Embla Systems · Anesthesiology device
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Mar 2019
Decision
442d
Days
Class 2
Risk

K173793 is an FDA 510(k) clearance for the XactTrace Single Use Respiratory Effort Belt System. Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by Embla Systems (Kanata, CA). The FDA issued a Cleared decision on March 1, 2019 after a review of 442 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Embla Systems devices

Submission Details

510(k) Number K173793 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2017
Decision Date March 01, 2019
Days to Decision 442 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
302d slower than avg
Panel avg: 140d · This submission: 442d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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. 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 60
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