Cleared Traditional

K821129 - AIRLIFE NEBULIZER HEATER

K821129 is an FDA 510(k) clearance for AIRLIFE NEBULIZER HEATER, manufactured by Airlife, Inc.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K821129 · Airlife, Inc. · Anesthesiology device
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May 1982
Decision
28d
Days
Class 2
Risk

K821129 is an FDA 510(k) clearance for the AIRLIFE NEBULIZER HEATER. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Airlife, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 18, 1982 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5630 - 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

FDA 510(k) Submission Details - K821129

510(k) Number K821129 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1982
Decision Date May 18, 1982
Days to Decision 28 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
112d faster than avg
Panel avg: 140d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAF Device Classification - Class 2, Special Controls

Product Code CAF Nebulizer (direct Patient Interface)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5630
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - CAF Nebulizer (direct Patient Interface)

All 229
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K821129.
DISPOS. MEDICATION NEBULIZER
K831270 · Hospitak, Inc. · Jun 1983
SINGLE USE NEBULIZER, ADJUST. AIR-
K830895 · Airlife, Inc. · Apr 1983
PREFILLED RESPIRATORY THERAPY VIAL
K830943 · Automatic Liquid Packaging, Inc. · Apr 1983
OPTI-MIST
K820952 · Corpak Co. · Apr 1982
NEBULIZER HEATER
K810217 · Corpak Co. · Mar 1981
PREFILLED NEBULIZER
K810218 · Corpak Co. · Mar 1981