Cleared Traditional

K823858 - VOLUME VENTILATOR

K823858 is an FDA 510(k) clearance for VOLUME VENTILATOR, manufactured by Puritan Bennett Corp.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway .

K823858 · Puritan Bennett Corp. · Anesthesiology device
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Dec 1982
Decision
-
Days
Class 2
Risk

K823858 is an FDA 510(k) clearance for the VOLUME VENTILATOR. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Puritan Bennett Corp. (Walker, US). The FDA issued a Cleared decision on December 22, 1982.

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 - K823858

510(k) Number K823858 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1982
Decision Date December 22, 1982
Days to Decision -
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
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 K823858.
MICROPROCESSOR VENTILATOR 7200
K833786 · Puritan Bennett Corp. · Dec 1983
PZ-800 VOLUME VENTILATOR
K822835 · Narco Scientific · Sep 1983
VENTILATOR #1
K830488 · Ohio Medical Products · Sep 1983
225 S.I.M.V. VENTILATOR
K822635 · Monaghan Medical Corp. · Nov 1982
OHIO CPU-1 INTENSIVE CARE VENTILATOR
K822888 · Ohio Medical Products · Nov 1982
ABT 4000 VENTILATOR
K822233 · Kontron Instruments, Inc. · Aug 1982