Cleared Abbreviated

Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child, Disposable BreathSensor Preemie, Disposable BreathSensor Infant (K180001) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K180001 · Embla Systems · Anesthesiology device
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Sep 2019
Decision
633d
Days
Class 2
Risk

K180001 is an FDA 510(k) clearance for the Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child, D.... 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 September 27, 2019 after a review of 633 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: High-complexity regulatory submission. Standards-verified equivalence. 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 K180001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2018
Decision Date September 27, 2019
Days to Decision 633 days
Submission Type Abbreviated
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
494d slower than avg
Panel avg: 139d · This submission: 633d
Pathway characteristics
Standards-based clearance path.

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.