Cleared Traditional

K831238 - OXYMED

K831238 is an FDA 510(k) clearance for OXYMED, manufactured by Draeger Medical, Inc.. The device is a Class 2 Anesthesiology device with product code CCL cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K831238 · Draeger Medical, Inc. · Anesthesiology device
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May 1983
Decision
24d
Days
Class 2
Risk

K831238 is an FDA 510(k) clearance for the OXYMED. Classified as Analyzer, Gas, Oxygen, Gaseous-phase (product code CCL), Class II - Special Controls.

Submitted by Draeger Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 9, 1983 after a review of 24 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 Draeger Medical, Inc. devices

FDA 510(k) Submission Details - K831238

510(k) Number K831238 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1983
Decision Date May 09, 1983
Days to Decision 24 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
116d faster than avg
Panel avg: 140d · This submission: 24d
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 42
Devices cleared under the same product code (CCL) and FDA review panel - the closest regulatory comparables to K831238.
NOVOX OXYGEN ANALYZER 400
K840392 · Novametrix Medical Systems, Inc. · Feb 1984
OXYGEN ANALYZER 200
K840361 · Salter Labs · Feb 1984
BIO-TEK PERCENT OXYGEN MONITOR 74222
K831522 · Bio-Tek Instruments, Inc. · Sep 1983
OPTION A02 MODEL 15202A
K830124 · Hewlett-Packard Co. · Feb 1983
OXYGEN MONITOR IL 408
K823374 · Instrumentation Laboratory CO · Dec 1982
MK 808 SERIES NASAL OXYGEN SAMPLER
K822608 · Instrumentation Industries, Inc. · Oct 1982