Cleared Traditional

K152664 - TAV System (FDA 510(k) Clearance)

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

K152664 · New Aera, Inc. · Anesthesiology device
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Dec 2016
Decision
442d
Days
Class 2
Risk

K152664 is an FDA 510(k) clearance for the TAV System. Classified as Mechanical Ventilator (product code ONZ), Class II - Special Controls.

Submitted by New Aera, Inc. (San Ramon, US). The FDA issued a Cleared decision on December 2, 2016 after a review of 442 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all New Aera, Inc. devices

Submission Details

510(k) Number K152664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2015
Decision Date December 02, 2016
Days to Decision 442 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
303d slower than avg
Panel avg: 139d · This submission: 442d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ONZ Mechanical Ventilator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5895
Definition This Device Is A Volume Assist Ventilator Intended To Aid Adult Patients With Respiratory Insufficiency. It Is Designed For Patients Who Are Capable Of Spontaneously Breathing A Minimum Tidal Volume Of 3.5cc/kg Of Predicted Body Weight. The Device Is Designed For Continuous Applications Such As Patient Ambulation, Physical Therapy, Occupational Therapy, Respiratory Therapy, And Other Rehabilitation Efforts In An Institutional Or Home Care Environment. The Device Is Intended For Operation By Trained Personnel, Patients Or Caregiver Under The Direction Of A Physician,
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.