Cleared Traditional

K854202 - ANESTHESIA VENTILATOR MODEL 100

K854202 is an FDA 510(k) clearance for ANESTHESIA VENTILATOR MODEL 100, manufactured by Rusz Instruments, Inc.. The device is a Class 2 Anesthesiology device with product code CAD cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K854202 · Rusz Instruments, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1986
Decision
178d
Days
Class 2
Risk

K854202 is an FDA 510(k) clearance for the ANESTHESIA VENTILATOR MODEL 100. Classified as Vaporizer, Anesthesia, Non-heated (product code CAD), Class II - Special Controls.

Submitted by Rusz Instruments, Inc. (Pittsfield, US). The FDA issued a Cleared decision on April 11, 1986 after a review of 178 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5880 - 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.

FDA 510(k) Submission Details - K854202

510(k) Number K854202 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1985
Decision Date April 11, 1986
Days to Decision 178 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 140d · This submission: 178d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAD Device Classification - Class 2, Special Controls

Product Code CAD Vaporizer, Anesthesia, Non-heated
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5880
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 - CAD Vaporizer, Anesthesia, Non-heated

All 43
Devices cleared under the same product code (CAD) and FDA review panel - the closest regulatory comparables to K854202.
OHMEDA TEC 5 CONTINUOUS FLOW VAPORIZER
K892057 · Ohmeda Medical · Apr 1989
VAPAMASTA 5
K884686 · Dentsply Intl. · Mar 1989
VAPLOK
K864605 · Bear Medical Systems, Inc. · Feb 1987
HALOTHANE VAPORIZER 950, ENFLURANE
K841157 · Siemens Elema AB · Jun 1984
MODULUS VERNI-TROL ANESTHETIC VAPORIZER
K821966 · Ohio Medical Products · Jul 1982
DRAGER VAPOR 19.1 ANESTHETIC VAPORIZERS
K821650 · Draeger Medical, Inc. · Jun 1982
K854202 · ANESTHESIA VENTILATOR MODEL 100
Download PDF Rusz Instruments, Inc.