Cleared Traditional

K850964 - DOUBLE-SWIVEL CONNECTOR

K850964 is the FDA 510(k) clearance for DOUBLE-SWIVEL CONNECTOR by Sheridan Catheter Corp.. It is a Class 1 Anesthesiology device (product code BZA) cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K850964 · Sheridan Catheter Corp. · Anesthesiology device
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May 1985
Decision
67d
Days
Class 1
Risk

K850964 is an FDA 510(k) clearance for the DOUBLE-SWIVEL CONNECTOR. Classified as Connector, Airway (extension) (product code BZA), Class I - General Controls.

Submitted by Sheridan Catheter Corp. (Argyle, US). The FDA issued a Cleared decision on May 14, 1985 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5810 - 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 Sheridan Catheter Corp. devices

Submission Details

510(k) Number K850964 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1985
Decision Date May 14, 1985
Days to Decision 67 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 140d · This submission: 67d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BZA Connector, Airway (extension)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5810
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 - BZA Connector, Airway (extension)

All 18
Devices cleared under the same product code (BZA) and FDA review panel - the closest regulatory comparables to K850964.
FLEX-ELBOW
K912652 · Vital Signs, Inc. · Oct 1991
BAXTER BAFFLED TEE ADAPTER
K895014 · Baxter Healthcare Corp · Oct 1989
SHILEY ELBOW 15MM SWIVEL CONNECTOR
K895388 · Shiley, Inc. · Oct 1989
ARGYLE 15MM SWIVEL CONNECTOR
K850625 · Sherwood Medical Co. · Mar 1985
OHMEDA DOUBLE SWIVEL ADAPTER
K844656 · Ohmeda Medical · Feb 1985
INSPIRATORY FORCE PRESSURE ADAPTOR
K812067 · Airlife, Inc. · Aug 1981