Cleared Traditional

K093416 - TRILOGY 200 VENTILATOR

K093416 is an FDA 510(k) clearance for TRILOGY 200 VENTILATOR, manufactured by Respironics, Inc.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K093416 · Respironics, Inc. · Anesthesiology device
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Jan 2010
Decision
88d
Days
Class 2
Risk

K093416 is an FDA 510(k) clearance for the TRILOGY 200 VENTILATOR. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on January 29, 2010 after a review of 88 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Respironics, Inc. devices

FDA 510(k) Submission Details - K093416

510(k) Number K093416 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2009
Decision Date January 29, 2010
Days to Decision 88 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
52d faster than avg
Panel avg: 140d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBK Device Classification - Class 2, Special Controls

Product Code CBK Ventilator, Continuous, Facility Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5895
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 - CBK Ventilator, Continuous, Facility Use

All 249
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K093416.
ESPRIT VENTILATOR WITH AF531 SE FULL FACE MASK
K101129 · Respironics, Inc. · Sep 2010
TRILOGY 202 VENTILATOR
K093905 · Respironics, Inc. · May 2010
HAMILTON-C2
K092148 · Hamilton Medical AG · Mar 2010
UNI-VENT-731 SERIES VENTILATORS, MODEL 731EMV+
K091238 · Impact Instrumentation, Inc. · Aug 2009
HAMILTON-C2
K090468 · Hamilton Medical AG · Jun 2009
HOSPITAL FULL FACE MASK NON VENTED, MODEL: RT041
K083122 · Fisher &Paykel Healthcare , Ltd. · Mar 2009