Cleared Traditional

K190853 - Vyntus BODY

K190853 is an FDA 510(k) clearance for Vyntus BODY, manufactured by Vyaire Medical, Inc.. The device is a Class 2 Anesthesiology device with product code BZC cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K190853 · Vyaire Medical, Inc. · Anesthesiology device
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Aug 2019
Decision
136d
Days
Class 2
Risk

K190853 is an FDA 510(k) clearance for the Vyntus BODY. Classified as Calculator, Pulmonary Function Data (product code BZC), Class II - Special Controls.

Submitted by Vyaire Medical, Inc. (Mettawa, US). The FDA issued a Cleared decision on August 16, 2019 after a review of 136 days - within the typical 510(k) review window.

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 Vyaire Medical, Inc. devices

FDA 510(k) Submission Details - K190853

510(k) Number K190853 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2019
Decision Date August 16, 2019
Days to Decision 136 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
4d faster than avg
Panel avg: 140d · This submission: 136d
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 22
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