Cleared Traditional

K852823 - DMA OXYGEN MONITOR

K852823 is the FDA 510(k) clearance for DMA OXYGEN MONITOR by Ferguson Medical. It is a Class 2 Anesthesiology device (product code CCL) cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K852823 · Ferguson Medical · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1985
Decision
120d
Days
Class 2
Risk

K852823 is an FDA 510(k) clearance for the DMA OXYGEN MONITOR. Classified as Analyzer, Gas, Oxygen, Gaseous-phase (product code CCL), Class II - Special Controls.

Submitted by Ferguson Medical (Chico, US). The FDA issued a Cleared decision on October 29, 1985 after a review of 120 days - within the typical 510(k) review window.

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: 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 Ferguson Medical devices

Submission Details

510(k) Number K852823 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1985
Decision Date October 29, 1985
Days to Decision 120 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
20d faster than avg
Panel avg: 140d · This submission: 120d
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 38
Devices cleared under the same product code (CCL) and FDA review panel - the closest regulatory comparables to K852823.
SL02 OXYGEN ANALYZER
K881472 · Salter Labs · Jun 1988
SL01 OXYGEN ANALYZER
K881473 · Salter Labs · Jun 1988
SERVO GAS MONITOR 120
K861625 · Siemens Elema AB · May 1986
OHMEDA 5120 OXYGEN MONITOR
K853082 · Ohmeda Medical · Jul 1985
ENGSTROM ELIZA DUO CO2 & O2 ANALYZ
K840645 · Gambro, Inc. · Apr 1984
MONITOR 5590- ANALYZER 5595EC
K840565 · Hudson Oxygen Therapy Sales Co. · Apr 1984