Cleared Traditional

K912763 - OHMEDA STYLE CHECK UNITS (FEMALE COUPLERS)

K912763 is the FDA 510(k) clearance for OHMEDA STYLE CHECK UNITS (FEMALE COUPLERS) by Medical Fittings, Inc.. It is a Class 1 Anesthesiology device (product code BYX) cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K912763 · Medical Fittings, Inc. · Anesthesiology device
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Oct 1991
Decision
113d
Days
Class 1
Risk

K912763 is an FDA 510(k) clearance for the OHMEDA STYLE CHECK UNITS (FEMALE COUPLERS). Classified as Tubing, Pressure And Accessories (product code BYX), Class I - General Controls.

Submitted by Medical Fittings, Inc. (Northampton, US). The FDA issued a Cleared decision on October 15, 1991 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5860 - 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 Medical Fittings, Inc. devices

Submission Details

510(k) Number K912763 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1991
Decision Date October 15, 1991
Days to Decision 113 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 140d · This submission: 113d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BYX Tubing, Pressure And Accessories
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5860
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - BYX Tubing, Pressure And Accessories

All 8
Devices cleared under the same product code (BYX) and FDA review panel - the closest regulatory comparables to K912763.
OXYGEN TUBING (CRUSH RESISTANT)/VINYL TP
K801190 · Airlife, Inc. · May 1980
CORRUGATED FLEXIBLE POLYETHYLENE & EVA
K791821 · Airlife, Inc. · Sep 1979
TUBING CORRUGATED
K790147 · Airlife, Inc. · Feb 1979
TUBING, E.V.A. FLEXIBLE
K790158 · Airlife, Inc. · Feb 1979
CORRUGATED FLEXIBLE E.V.A. TUBING
K790159 · Airlife, Inc. · Feb 1979
OXYGEN TUBING, W/VINYL AND LATEX TIPS
K790160 · Airlife, Inc. · Feb 1979