Cleared Traditional

K905094 - SCHRADER OXYGEN/AIR VAC&NITR-OXIDE MALE QUICK CONN (FDA 510(k) Clearance)

Class I Anesthesiology device.

K905094 · Medical Fittings, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1990
Decision
7d
Days
Class 1
Risk

K905094 is an FDA 510(k) clearance for the SCHRADER OXYGEN/AIR VAC&NITR-OXIDE MALE QUICK CONN. 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 November 20, 1990 after a review of 7 days - a notably fast clearance cycle.

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: 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 Medical Fittings, Inc. devices

Submission Details

510(k) Number K905094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1990
Decision Date November 20, 1990
Days to Decision 7 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
132d faster than avg
Panel avg: 139d · This submission: 7d
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.