Cleared Traditional

K822835 - PZ-800 VOLUME VENTILATOR

K822835 is an FDA 510(k) clearance for PZ-800 VOLUME VENTILATOR, manufactured by Narco Scientific. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 373-day FDA review.

K822835 · Narco Scientific · Anesthesiology device
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Sep 1983
Decision
373d
Days
Class 2
Risk

K822835 is an FDA 510(k) clearance for the PZ-800 VOLUME VENTILATOR. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Narco Scientific. The FDA issued a Cleared decision on September 29, 1983 after a review of 373 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Narco Scientific devices

FDA 510(k) Submission Details - K822835

510(k) Number K822835 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 1982
Decision Date September 29, 1983
Days to Decision 373 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
233d slower than avg
Panel avg: 140d · This submission: 373d
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 327
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K822835.
MICROPROCESSOR VENTILATOR 7200
K833786 · Puritan Bennett Corp. · Dec 1983
PNEU PAC VENTILATOR/RESUSCITATORS
K832700 · Pneupac , Ltd. · Nov 1983
PORTABLE LIFECARE VENTILATOR PLV-100
K832467 · Lifecare Services, Inc. · Oct 1983
VENTILATOR #1
K830488 · Ohio Medical Products · Sep 1983
VOLUME VENTILATOR
K823858 · Puritan Bennett Corp. · Dec 1982
225 S.I.M.V. VENTILATOR
K822635 · Monaghan Medical Corp. · Nov 1982