Cleared Traditional

Vyntus/SentrySuite Product Line (K183567) - FDA 510(k) Clearance

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

K183567 · Vyaire Medical · Anesthesiology device
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Aug 2019
Decision
245d
Days
Class 2
Risk

K183567 is an FDA 510(k) clearance for the Vyntus/SentrySuite Product Line. Classified as Calculator, Pulmonary Function Data (product code BZC), Class II - Special Controls.

Submitted by Vyaire Medical (Hoechber, DE). The FDA issued a Cleared decision on August 23, 2019 after a review of 245 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 Vyaire Medical devices

Submission Details

510(k) Number K183567 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2018
Decision Date August 23, 2019
Days to Decision 245 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
106d slower than avg
Panel avg: 139d · This submission: 245d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 89
Devices cleared under the same product code (BZC) and FDA review panel - the closest regulatory comparables to K183567.
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K802920 · C.R. Bard, Inc. · Feb 1981