Cleared Traditional

K162515 - COSMED K5 Wearable Metabolic Technology

K162515 is an FDA 510(k) clearance for COSMED K5 Wearable Metabolic Technology, manufactured by Cosmed Srl. The device is a Class 2 Anesthesiology device with product code BZC cleared through the Traditional 510(k) pathway after a 285-day FDA review.

K162515 · Cosmed Srl · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2017
Decision
285d
Days
Class 2
Risk

K162515 is an FDA 510(k) clearance for the COSMED K5 Wearable Metabolic Technology. Classified as Calculator, Pulmonary Function Data (product code BZC), Class II - Special Controls.

Submitted by Cosmed Srl (Pavona Di Albano Rome, IT). The FDA issued a Cleared decision on June 20, 2017 after a review of 285 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1880 - 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 Cosmed Srl devices

FDA 510(k) Submission Details - K162515

510(k) Number K162515 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2016
Decision Date June 20, 2017
Days to Decision 285 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
145d slower than avg
Panel avg: 140d · This submission: 285d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZC Device Classification - Class 2, Special Controls

Product Code BZC Calculator, Pulmonary Function Data
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1880
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 - BZC Calculator, Pulmonary Function Data

All 23
Devices cleared under the same product code (BZC) and FDA review panel - the closest regulatory comparables to K162515.
Vyntus/SentrySuite Product Line
K183567 · Vyaire Medical · Aug 2019
Vyntus BODY
K190853 · Vyaire Medical, Inc. · Aug 2019
Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART
K181524 · Vyaire Medical, Inc. · Nov 2018
COSMO PLUS WITH NICO, MODEL 8200
K982499 · Novametrix Medical Systems, Inc. · Oct 1998
VENT(VENTCHECK) HANDHELD RESPIRATORY/MECHANICS MONITOR MODEL 101
K964360 · Novametrix Medical Systems, Inc. · Apr 1997
CO 2 SMO PLUS
K963380 · Novametrix Medical Systems, Inc. · Jan 1997