Cleared Traditional

K822608 - MK 808 SERIES NASAL OXYGEN SAMPLER

K822608 is the FDA 510(k) clearance for MK 808 SERIES NASAL OXYGEN SAMPLER by Instrumentation Industries, Inc.. It is a Class 2 Anesthesiology device (product code CCL) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K822608 · Instrumentation Industries, Inc. · Anesthesiology device
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Oct 1982
Decision
35d
Days
Class 2
Risk

K822608 is an FDA 510(k) clearance for the MK 808 SERIES NASAL OXYGEN SAMPLER. Classified as Analyzer, Gas, Oxygen, Gaseous-phase (product code CCL), Class II - Special Controls.

Submitted by Instrumentation Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 4, 1982 after a review of 35 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 Instrumentation Industries, Inc. devices

Submission Details

510(k) Number K822608 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1982
Decision Date October 04, 1982
Days to Decision 35 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
105d faster than avg
Panel avg: 140d · This submission: 35d
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 32
Devices cleared under the same product code (CCL) and FDA review panel - the closest regulatory comparables to K822608.
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
MONITOR, OXYCHEK OXYGEN
K782114 · Critikon Company, LLC · Jan 1979
MONITOR, OXYGEN, MODEL 78216C
K770207 · Hewlett-Packard Co. · Feb 1977
MONITOR, RESP. OXYGEN (TOP)
K760338 · Sherwood Medical Industries · Aug 1976