Cleared Traditional

K895388 - SHILEY ELBOW 15MM SWIVEL CONNECTOR

K895388 is an FDA 510(k) clearance for SHILEY ELBOW 15MM SWIVEL CONNECTOR, manufactured by Shiley, Inc.. The device is a Class 1 Anesthesiology device with product code BZA cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K895388 · Shiley, Inc. · Anesthesiology device
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Oct 1989
Decision
58d
Days
Class 1
Risk

K895388 is an FDA 510(k) clearance for the SHILEY ELBOW 15MM SWIVEL CONNECTOR. Classified as Connector, Airway (extension) (product code BZA), Class I - General Controls.

Submitted by Shiley, Inc. (Irvine, US). The FDA issued a Cleared decision on October 27, 1989 after a review of 58 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 Shiley, Inc. devices

FDA 510(k) Submission Details - K895388

510(k) Number K895388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1989
Decision Date October 27, 1989
Days to Decision 58 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
82d faster than avg
Panel avg: 140d · This submission: 58d
Pathway characteristics
Predicate-based equivalence.

BZA Device Classification - Class 1, General Controls

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 35
Devices cleared under the same product code (BZA) and FDA review panel - the closest regulatory comparables to K895388.
FLEX-ELBOW
K912652 · Vital Signs, Inc. · Oct 1991
AEROVENT
K894969 · Monaghan Medical Corp. · Oct 1989
BAXTER BAFFLED TEE ADAPTER
K895014 · Baxter Healthcare Corp · Oct 1989
FLEX TUBE
K881230 · Intertech Resources, Inc. · Apr 1988
SALTER LABS MODEL #4005 GAS SAMPLING TEE AND LINE
K865046 · Salter Labs · Jan 1987
BRITISH BREATHING CIRCUIT SYSTEM
K860878 · Dhd Medical Products Div. Diemolding Corp. · Mar 1986