Cleared Special

K041412 - ESPRIT VENTILATOR WITH NICO-ESPRIT INTE...

K041412 is an FDA 510(k) clearance for ESPRIT VENTILATOR WITH NICO-ESPRIT INTE..., manufactured by Respironics California, Inc.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Special 510(k) pathway after a 22-day FDA review.

K041412 · Respironics California, Inc. · Anesthesiology device
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Jun 2004
Decision
22d
Days
Class 2
Risk

K041412 is an FDA 510(k) clearance for the ESPRIT VENTILATOR WITH NICO-ESPRIT INTERFACE OPTION, MODEL V1000. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Respironics California, Inc. (Carlsbad, US). The FDA issued a Cleared decision on June 18, 2004 after a review of 22 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Respironics California, Inc. devices

FDA 510(k) Submission Details - K041412

510(k) Number K041412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2004
Decision Date June 18, 2004
Days to Decision 22 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 140d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

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 327
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