Cleared Traditional

MODEL 840 VENTILATOR WITH PROPORTIONAL ASSIST VENTILATION PLUS SOFTWARE OPTION

K053388 · Puritan Bennett Corp. · Anesthesiology
Apr 2006
Decision
120d
Days
Class 2
Risk

About This 510(k) Submission

K053388 is an FDA 510(k) clearance for the MODEL 840 VENTILATOR WITH PROPORTIONAL ASSIST VENTILATION PLUS SOFTWARE OPTION, a Ventilator, Continuous, Facility Use (Class II — Special Controls, product code CBK), submitted by Puritan Bennett Corp. (Pleasanton, US). The FDA issued a Cleared decision on April 4, 2006, 120 days after receiving the submission on December 5, 2005. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K053388 FDA.gov
FDA Decision Cleared 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

Device Classification

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

Similar Devices — CBK Ventilator, Continuous, Facility Use

All 502
VPAP Pediatric Face Mask
K251888 · Hsiner Co., Ltd. · Mar 2026
Vivo 45 LS
K232365 · Oconnell Regulatory Consultants, Inc. · Dec 2025
F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits ? Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits ? Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits ? Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented Full
K252173 · Fisher &Paykel Healthcare , Ltd. · Sep 2025
SV600, SV800 Ventilator
K243767 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Aug 2025
AVEA disposable expiratory filter/water trap (11790)
K251133 · Telesair, Inc. · May 2025
AF531 Oro-Nasal SE Face Mask
K243394 · Respironics, Inc. · Dec 2024