Cleared Traditional

K894969 - AEROVENT

K894969 is an FDA 510(k) clearance for AEROVENT, manufactured by Monaghan Medical Corp.. The device is a Class 1 Anesthesiology device with product code BZA cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K894969 · Monaghan Medical Corp. · Anesthesiology device
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Oct 1989
Decision
84d
Days
Class 1
Risk

K894969 is an FDA 510(k) clearance for the AEROVENT. Classified as Connector, Airway (extension) (product code BZA), Class I - General Controls.

Submitted by Monaghan Medical Corp. (Plattsburgh, US). The FDA issued a Cleared decision on October 30, 1989 after a review of 84 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 Monaghan Medical Corp. devices

FDA 510(k) Submission Details - K894969

510(k) Number K894969 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1989
Decision Date October 30, 1989
Days to Decision 84 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
56d faster than avg
Panel avg: 140d · This submission: 84d
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 39
Devices cleared under the same product code (BZA) and FDA review panel - the closest regulatory comparables to K894969.
AIRWAY CONNECTOR WITH FLEX TUBE
K942392 · Mallinckrodt Medical · Aug 1994
MERIDIAN MEDICAL SYSTEMS CONNECTORS & AIRWAY EXT
K925263 · Merit Medical Systems, Inc. · Feb 1993
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
BODAI M.D.D. ADAPTOR(TM)
K881849 · B&B Medical Technologies, Inc. · Jul 1988