Cleared Traditional

K840361 - OXYGEN ANALYZER 200

K840361 is an FDA 510(k) clearance for OXYGEN ANALYZER 200, manufactured by Salter Labs. The device is a Class 2 Anesthesiology device with product code CCL cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K840361 · Salter Labs · Anesthesiology device
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Feb 1984
Decision
22d
Days
Class 2
Risk

K840361 is an FDA 510(k) clearance for the OXYGEN ANALYZER 200. Classified as Analyzer, Gas, Oxygen, Gaseous-phase (product code CCL), Class II - Special Controls.

Submitted by Salter Labs (Mchenry, US). The FDA issued a Cleared decision on February 17, 1984 after a review of 22 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 Salter Labs devices

FDA 510(k) Submission Details - K840361

510(k) Number K840361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1984
Decision Date February 17, 1984
Days to Decision 22 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
118d faster than avg
Panel avg: 140d · This submission: 22d
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 K840361.
ENGSTROM ELIZA DUO CO2 & O2 ANALYZ
K840645 · Gambro, Inc. · Apr 1984
MONITOR 5590- ANALYZER 5595EC
K840565 · Hudson Oxygen Therapy Sales Co. · Apr 1984
NOVOX OXYGEN ANALYZER 400
K840392 · Novametrix Medical Systems, Inc. · Feb 1984
BIO-TEK PERCENT OXYGEN MONITOR 74222
K831522 · Bio-Tek Instruments, Inc. · Sep 1983
OXYMED
K831238 · Draeger Medical, Inc. · May 1983
OPTION A02 MODEL 15202A
K830124 · Hewlett-Packard Co. · Feb 1983