Cleared Traditional

K840565 - MONITOR 5590- ANALYZER 5595EC

K840565 is the FDA 510(k) clearance for MONITOR 5590- ANALYZER 5595EC by Hudson Oxygen Therapy Sales Co.. It is a Class 2 Anesthesiology device (product code CCL) cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K840565 · Hudson Oxygen Therapy Sales Co. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1984
Decision
54d
Days
Class 2
Risk

K840565 is an FDA 510(k) clearance for the MONITOR 5590- ANALYZER 5595EC. Classified as Analyzer, Gas, Oxygen, Gaseous-phase (product code CCL), Class II - Special Controls.

Submitted by Hudson Oxygen Therapy Sales Co. (Mchenry, US). The FDA issued a Cleared decision on April 2, 1984 after a review of 54 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 Hudson Oxygen Therapy Sales Co. devices

Submission Details

510(k) Number K840565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1984
Decision Date April 02, 1984
Days to Decision 54 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 140d · This submission: 54d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 20
Devices cleared under the same product code (CCL) and FDA review panel - the closest regulatory comparables to K840565.
OHMEDA 5250 RGM (RESPIRATORY GAS MONITOR)
K882743 · Ohmeda Medical · Aug 1988
OHMEDA 5120 OXYGEN MONITOR
K853082 · Ohmeda Medical · Jul 1985
ENGSTROM ELIZA DUO CO2 & O2 ANALYZ
K840645 · Gambro, Inc. · Apr 1984
OXYMED
K831238 · Draeger Medical, Inc. · May 1983
OPTION A02 MODEL 15202A
K830124 · Hewlett-Packard Co. · Feb 1983
OXYGEN MONITOR IL 408
K823374 · Instrumentation Laboratory CO · Dec 1982