Cleared Traditional

K833335 - MODULUS II ANESTHESIA GAS MACHINE

K833335 is an FDA 510(k) clearance for MODULUS II ANESTHESIA GAS MACHINE, manufactured by Ohio Medical Products. The device is a Class 2 Anesthesiology device with product code BSZ cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K833335 · Ohio Medical Products · Anesthesiology device
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Nov 1983
Decision
48d
Days
Class 2
Risk

K833335 is an FDA 510(k) clearance for the MODULUS II ANESTHESIA GAS MACHINE. Classified as Gas-machine, Anesthesia (product code BSZ), Class II - Special Controls.

Submitted by Ohio Medical Products (Mchenry, US). The FDA issued a Cleared decision on November 14, 1983 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5160 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ohio Medical Products devices

FDA 510(k) Submission Details - K833335

510(k) Number K833335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1983
Decision Date November 14, 1983
Days to Decision 48 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
92d faster than avg
Panel avg: 140d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BSZ Device Classification - Class 2, Special Controls

Product Code BSZ Gas-machine, Anesthesia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5160
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 - BSZ Gas-machine, Anesthesia

All 118
Devices cleared under the same product code (BSZ) and FDA review panel - the closest regulatory comparables to K833335.
OHIO UNITROL II ANESTHESIA GAS MACHINE
K840356 · Ohio Medical Products · Apr 1984
BAG-TO-VENTILATOR SELECTOR VALVE
K841274 · Ohio Medical Products · Apr 1984
CENTRALERT
K833147 · Draeger Medical, Inc. · Dec 1983
AIR-SHIELDS VENTIMETER VENTILATOR-CONTR
K830680 · Narco Scientific · Apr 1983
NARKOMED 2A ANESTHESIA MACHINE
K822218 · Draeger Medical, Inc. · Sep 1982
OHIO MODULAR ANESTHESIA GAS MACHINE
K791530 · Ohio Medical Products · Sep 1979