Cleared Traditional

K190800 - Cosmed Q-NRG / Q-NRG+ Portable Metaboli...

K190800 is an FDA 510(k) clearance for Cosmed Q-NRG / Q-NRG+ Portable Metaboli..., manufactured by Cosmed Srl. The device is a Class 2 Anesthesiology device with product code BTY cleared through the Traditional 510(k) pathway after a 315-day FDA review.

K190800 · Cosmed Srl · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Feb 2020
Decision
315d
Days
Class 2
Risk

K190800 is an FDA 510(k) clearance for the Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors. Classified as Calculator, Predicted Values, Pulmonary Function (product code BTY), Class II - Special Controls.

Submitted by Cosmed Srl (Rome, IT). The FDA issued a Cleared decision on February 6, 2020 after a review of 315 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1890 - 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 Cosmed Srl devices

FDA 510(k) Submission Details - K190800

510(k) Number K190800 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2019
Decision Date February 06, 2020
Days to Decision 315 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
175d slower than avg
Panel avg: 140d · This submission: 315d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTY Device Classification - Class 2, Special Controls

Product Code BTY Calculator, Predicted Values, Pulmonary Function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1890
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

Donawa Lifescience Consulting Srl
Roger Gray

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 - BTY Calculator, Predicted Values, Pulmonary Function

All 14
Devices cleared under the same product code (BTY) and FDA review panel - the closest regulatory comparables to K190800.
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