Cleared Traditional

K853082 - OHMEDA 5120 OXYGEN MONITOR

K853082 is an FDA 510(k) clearance for OHMEDA 5120 OXYGEN MONITOR, manufactured by Ohmeda Medical. The device is a Class 2 Anesthesiology device with product code CCL cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K853082 · Ohmeda Medical · Anesthesiology device
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Jul 1985
Decision
8d
Days
Class 2
Risk

K853082 is an FDA 510(k) clearance for the OHMEDA 5120 OXYGEN MONITOR. Classified as Analyzer, Gas, Oxygen, Gaseous-phase (product code CCL), Class II - Special Controls.

Submitted by Ohmeda Medical (Madison, US). The FDA issued a Cleared decision on July 31, 1985 after a review of 8 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1720 - 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 Ohmeda Medical devices

FDA 510(k) Submission Details - K853082

510(k) Number K853082 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1985
Decision Date July 31, 1985
Days to Decision 8 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
132d faster than avg
Panel avg: 140d · This submission: 8d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CCL Device Classification - Class 2, Special Controls

Product Code CCL Analyzer, Gas, Oxygen, Gaseous-phase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1720
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 - CCL Analyzer, Gas, Oxygen, Gaseous-phase

All 65
Devices cleared under the same product code (CCL) and FDA review panel - the closest regulatory comparables to K853082.
SERVO GAS MONITOR 120
K861625 · Siemens Elema AB · May 1986
EMERSON MODEL 3MV-OAA ALARM MODULE
K854799 · J. H. Emerson Co. · Dec 1985
DMA OXYGEN MONITOR
K852823 · Ferguson Medical · Oct 1985
O2 TEST
K843847 · Erich Jaeger, Inc. · Oct 1984
ENGSTROM ELIZA DUO CO2 & O2 ANALYZ
K840645 · Gambro, Inc. · Apr 1984
MONITOR 5590- ANALYZER 5595EC
K840565 · Hudson Oxygen Therapy Sales Co. · Apr 1984