Cleared Traditional

K840015 - SWIVEL ADAPTOR W/ALARM PORT

K840015 is an FDA 510(k) clearance for SWIVEL ADAPTOR W/ALARM PORT, manufactured by Portex, Inc.. The device is a Class 1 Anesthesiology device with product code BZA cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K840015 · Portex, Inc. · Anesthesiology device
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Jan 1984
Decision
13d
Days
Class 1
Risk

K840015 is an FDA 510(k) clearance for the SWIVEL ADAPTOR W/ALARM PORT. Classified as Connector, Airway (extension) (product code BZA), Class I - General Controls.

Submitted by Portex, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 17, 1984 after a review of 13 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 Portex, Inc. devices

FDA 510(k) Submission Details - K840015

510(k) Number K840015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1984
Decision Date January 17, 1984
Days to Decision 13 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
127d faster than avg
Panel avg: 140d · This submission: 13d
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 43
Devices cleared under the same product code (BZA) and FDA review panel - the closest regulatory comparables to K840015.
DOUBLE-SWIVEL CONNECTOR
K850964 · Sheridan Catheter Corp. · May 1985
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
PEDIATRIC DOUBLE SWIVEL CONNECTOR
K812000 · Mallinckrodt Critical Care · Aug 1981
45DEGREES SWIVEL ELBOW
K811922 · Dhd Medical Products Div. Diemolding Corp. · Jul 1981