Cleared Traditional

K781871 - DIFFUSION OPTION, OMNI-LAB

K781871 is an FDA 510(k) clearance for DIFFUSION OPTION, manufactured by Ohio Medical Products. The device is a Class 2 Anesthesiology device with product code CCJ cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K781871 · Ohio Medical Products · Anesthesiology device
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Jan 1979
Decision
60d
Days
Class 2
Risk

K781871 is an FDA 510(k) clearance for the DIFFUSION OPTION, OMNI-LAB. Classified as Analyzer, Gas, Carbon-monoxide, Gaseous-phase (product code CCJ), Class II - Special Controls.

Submitted by Ohio Medical Products (Mchenry, US). The FDA issued a Cleared decision on January 2, 1979 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1430 - 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 Ohio Medical Products devices

FDA 510(k) Submission Details - K781871

510(k) Number K781871 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1978
Decision Date January 02, 1979
Days to Decision 60 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
80d faster than avg
Panel avg: 140d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CCJ Device Classification - Class 2, Special Controls

Product Code CCJ Analyzer, Gas, Carbon-monoxide, Gaseous-phase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1430
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 - CCJ Analyzer, Gas, Carbon-monoxide, Gaseous-phase

All 12
Devices cleared under the same product code (CCJ) and FDA review panel - the closest regulatory comparables to K781871.
CD-102 CARBON DIOXIDE ANALYZER/RECOR
K833739 · Instrumentarium Corp. · Dec 1983
ECOLYZER #200/COHB ANALYZER SYS
K832655 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1983
ARGYLE DOUBLE SEAL CHEST DRAINAGE UNIT
K802891 · Sherwood Medical Co. · Dec 1980
DIFFUSION SYSTEM, SINGLE-BREATH (47404A)
K760169 · Hewlett-Packard Co. · Jul 1976