Cleared Traditional

K924225 - OXYGEN SWIVEL ADAPTER (PLASTIC)

K924225 is an FDA 510(k) clearance for OXYGEN SWIVEL ADAPTER (PLASTIC), manufactured by Linjorel Products, Inc.. The device is a Class 1 Anesthesiology device with product code BZA cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K924225 · Linjorel Products, Inc. · Anesthesiology device
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Sep 1992
Decision
14d
Days
Class 1
Risk

K924225 is an FDA 510(k) clearance for the OXYGEN SWIVEL ADAPTER (PLASTIC). Classified as Connector, Airway (extension) (product code BZA), Class I - General Controls.

Submitted by Linjorel Products, Inc. (Pittsburg, US). The FDA issued a Cleared decision on September 4, 1992 after a review of 14 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.

FDA 510(k) Submission Details - K924225

510(k) Number K924225 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1992
Decision Date September 04, 1992
Days to Decision 14 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
126d faster than avg
Panel avg: 140d · This submission: 14d
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 66
Devices cleared under the same product code (BZA) and FDA review panel - the closest regulatory comparables to K924225.
CONNECTORS AND AIRWAY EXTENSIONS
K931038 · Med-Plastics Intl., Inc. · Apr 1993
MERIDIAN MEDICAL SYSTEMS CONNECTORS & AIRWAY EXT
K925263 · Merit Medical Systems, Inc. · Feb 1993
DURALIFE
K922537 · Dhd Diemolding Healthcare Div. · Dec 1992
CATHETER MOUNTS -- MODIFICATION
K921511 · Intersurgical, Inc. · Jun 1992
ENTENDED LINE ACCESSORIES & CONNECTORS
K921512 · Intersurgical, Inc. · Jun 1992
FLEX-ELBOW
K912652 · Vital Signs, Inc. · Oct 1991