Cleared Traditional

ComPAS2 (K213872) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K213872 · Morgan Scientific, Inc. · Anesthesiology device
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Jul 2022
Decision
214d
Days
Class 2
Risk

K213872 is an FDA 510(k) clearance for the ComPAS2. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Morgan Scientific, Inc. (Haverhill, US). The FDA issued a Cleared decision on July 15, 2022 after a review of 214 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1840 - 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 Morgan Scientific, Inc. devices

Submission Details

510(k) Number K213872 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2021
Decision Date July 15, 2022
Days to Decision 214 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
74d slower than avg
Panel avg: 140d · This submission: 214d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BZG Spirometer, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1840
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 - BZG Spirometer, Diagnostic

All 28
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K213872.
Alveoair Digital Spirometer
K222525 · Roundworks Technologies Private Limited · Aug 2023
Air Smart Extra Spirometer
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SpiroHome Personal, SpiroHome Clinic
K213754 · Inofab Saglik Teknolojileri A.S · Jun 2023
Vitalograph Model 6000 Alpha
K212938 · Vitalograph (Ireland) , Ltd. · Jan 2022
Spirometer
K201493 · Mehow Innovative, Ltd. · Jun 2021
GoSpiro
K202837 · Monitored Therapeutics, Inc. · Dec 2020