Cleared Traditional

K053388 - MODEL 840 VENTILATOR WITH PROPORTIONAL ...

K053388 is an FDA 510(k) clearance for MODEL 840 VENTILATOR WITH PROPORTIONAL ..., manufactured by Puritan Bennett Corp.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K053388 · Puritan Bennett Corp. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
120d
Days
Class 2
Risk

K053388 is an FDA 510(k) clearance for the MODEL 840 VENTILATOR WITH PROPORTIONAL ASSIST VENTILATION PLUS SOFTWARE OPTION. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Puritan Bennett Corp. (Pleasanton, US). The FDA issued a Cleared decision on April 4, 2006 after a review of 120 days - within the typical 510(k) review window.

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: 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 Puritan Bennett Corp. devices

FDA 510(k) Submission Details - K053388

510(k) Number K053388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2005
Decision Date April 04, 2006
Days to Decision 120 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
20d faster than avg
Panel avg: 140d · This submission: 120d
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 K053388.
GE DATEX-OHMEDA ENGSTROM CARESTATION
K062710 · Datex-Ohmeda, Inc. · Dec 2006
GALILEO GOLD ASV
K061090 · Hamilton Medical AG · Jul 2006
GE DATEX-OHMEDA ENGSTROM CARESTATION
K060862 · Datex-Ohmeda, Inc. · Jun 2006
RAPHAEL COLOR
K052863 · Hamilton Medical AG · Jan 2006
GE DATEX-OHMEDA ENGSTROM CARESTATION
K051895 · Datex-Ohmeda, Inc. · Sep 2005
GE DATEX-OHMEDA CENTIVA/5 VENTILATOR
K050860 · Datex-Ohmeda, Inc. · Jun 2005