Cleared Traditional

K023350 - ESPRIT VENTILATOR WITH RESPIRATORY MECHANICS

K023350 is an FDA 510(k) clearance for ESPRIT VENTILATOR WITH RESPIRATORY MECH..., manufactured by Respironics California, Inc.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K023350 · Respironics California, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2002
Decision
30d
Days
Class 2
Risk

K023350 is an FDA 510(k) clearance for the ESPRIT VENTILATOR WITH RESPIRATORY MECHANICS. 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 November 6, 2002 after a review of 30 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.

FDA 510(k) Submission Details - K023350

510(k) Number K023350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 2002
Decision Date November 06, 2002
Days to Decision 30 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
110d faster than avg
Panel avg: 140d · This submission: 30d
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 435
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K023350.
MONSOON CRITICAL CARE JET VENTILATOR AND ACCESSORIES
K012691 · Acutronic Medical Systems AG · Dec 2002
INSPIRATION VENTILATOR SYSTEM
K021112 · eVent Medical, Ltd. · Nov 2002
BIRD AVEA VENTILATOR
K022674 · Bird Products Corp. · Nov 2002
SERVO VENTILATOR SYSTEM, MODEL 64 87 800 E407E
K022132 · Siemens Medical Solutions USA, Inc. · Sep 2002
PURITAN-BENNETT 840 VENTILATIOR SYSTEM WITH VOLUME VENTILATION PLUS OPTION
K021573 · Puritan-Bennett · Aug 2002
MISTRAL CRITICAL CARE JET VENTILATOR AND ACCESSORIES
K012693 · Acutronic Medical Systems AG · Aug 2002