Cleared Traditional

K812067 - INSPIRATORY FORCE PRESSURE ADAPTOR

K812067 is the FDA 510(k) clearance for INSPIRATORY FORCE PRESSURE ADAPTOR by Airlife, Inc.. It is a Class 1 Anesthesiology device (product code BZA) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K812067 · Airlife, Inc. · Anesthesiology device
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Aug 1981
Decision
22d
Days
Class 1
Risk

K812067 is an FDA 510(k) clearance for the INSPIRATORY FORCE PRESSURE ADAPTOR. Classified as Connector, Airway (extension) (product code BZA), Class I - General Controls.

Submitted by Airlife, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 12, 1981 after a review of 22 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 Airlife, Inc. devices

Submission Details

510(k) Number K812067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1981
Decision Date August 12, 1981
Days to Decision 22 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
118d faster than avg
Panel avg: 140d · This submission: 22d
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 17
Devices cleared under the same product code (BZA) and FDA review panel - the closest regulatory comparables to K812067.
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
PEDIATRIC DOUBLE SWIVEL CONNECTOR
K812000 · Mallinckrodt Critical Care · Aug 1981
DISPOSABLE TRACH T OXYGENATOR
K811890 · Airlife, Inc. · Jul 1981
UNIVERSAL ADAPTER SYSTEM-U/ADAPIT
K811708 · Airlife, Inc. · Jul 1981