Cleared Traditional

K163249 - GoSpiro

K163249 is an FDA 510(k) clearance for GoSpiro, manufactured by Monitored Therapeutics, Inc.. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K163249 · Monitored Therapeutics, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2017
Decision
126d
Days
Class 2
Risk

K163249 is an FDA 510(k) clearance for the GoSpiro. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Monitored Therapeutics, Inc. (Dublin, US). The FDA issued a Cleared decision on March 24, 2017 after a review of 126 days - within the typical 510(k) review window.

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 Monitored Therapeutics, Inc. devices

FDA 510(k) Submission Details - K163249

510(k) Number K163249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 2016
Decision Date March 24, 2017
Days to Decision 126 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
14d faster than avg
Panel avg: 140d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZG Device Classification - Class 2, Special Controls

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 Consultant

ProMedic, LLC
Paul Dryden

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - BZG Spirometer, Diagnostic

All 122
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K163249.
Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option
K191013 · Welch Allyn, Inc. · Sep 2019
ComPAS2 (Computerized Pulmonary Analysis System)
K190568 · Morgan Scientific, Inc. · Jun 2019
Pulmonx Chartis Tablet Console
K180011 · Pulmonx Corporation · Jul 2018
EasyOne Air Spirometer
K161536 · Ndd Medizintechnik AG · Jan 2017
Q13 SPIROLYSER®
K161676 · Fim Medical · Oct 2016
SpiroScout
K160116 · Ganshorn Medizin Electronic GmbH · Oct 2016