Cleared Traditional

K912763 - OHMEDA STYLE CHECK UNITS (FEMALE COUPLERS)

K912763 is an FDA 510(k) clearance for OHMEDA STYLE CHECK UNITS (FEMALE COUPLERS), manufactured by Medical Fittings, Inc.. The device is a Class 1 Anesthesiology device with 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

FDA 510(k) Submission Details - K912763

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.

BYX Device Classification - Class 1, General Controls

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 26
Devices cleared under the same product code (BYX) and FDA review panel - the closest regulatory comparables to K912763.
NORTH STATE PLASTICS AEROSOL TEE
K955656 · North State Plastics, Inc. · Mar 1996
BUSSE PLASTIC TUBING CONNECTORS AND ACCESSORIES
K935835 · Busse Hospital Disposables, Inc. · Jan 1994
FLEXTUBE, CONNECTING TUBING
K860877 · Dhd Medical Products Div. Diemolding Corp. · Mar 1986
OXYCOIL
K854239 · Chad Therapeutics, Inc. · Nov 1985
MEDIPART CORRUGATED POLYETHYLENE & E.V.A. TUBING
K853569 · Medipart Jerry Alexander · Nov 1985
OXYMIZER FLOW RESTRICTOR
K841901 · Chad Therapeutics, Inc. · Jul 1984