Cleared Traditional

K830488 - VENTILATOR #1

K830488 is an FDA 510(k) clearance for VENTILATOR #1, manufactured by Ohio Medical Products. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K830488 · Ohio Medical Products · Anesthesiology device
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Sep 1983
Decision
212d
Days
Class 2
Risk

K830488 is an FDA 510(k) clearance for the VENTILATOR #1. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Ohio Medical Products (Walker, US). The FDA issued a Cleared decision on September 15, 1983 after a review of 212 days - an extended review 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: 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 Ohio Medical Products devices

FDA 510(k) Submission Details - K830488

510(k) Number K830488 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 1983
Decision Date September 15, 1983
Days to Decision 212 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
72d slower than avg
Panel avg: 140d · This submission: 212d
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 K830488.
PNEU PAC VENTILATOR/RESUSCITATORS
K832700 · Pneupac , Ltd. · Nov 1983
PORTABLE LIFECARE VENTILATOR PLV-100
K832467 · Lifecare Services, Inc. · Oct 1983
PZ-800 VOLUME VENTILATOR
K822835 · Narco Scientific · Sep 1983
VOLUME VENTILATOR
K823858 · Puritan Bennett Corp. · Dec 1982
225 S.I.M.V. VENTILATOR
K822635 · Monaghan Medical Corp. · Nov 1982
OHIO CPU-1 INTENSIVE CARE VENTILATOR
K822888 · Ohio Medical Products · Nov 1982