Cleared Traditional

K831162 - ENERGETIC HI-HUM AERSOL UNIT

K831162 is an FDA 510(k) clearance for ENERGETIC HI-HUM AERSOL UNIT, manufactured by Energetic Pulmonary. 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.

K831162 · Energetic Pulmonary · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1983
Decision
28d
Days
Class 2
Risk

K831162 is an FDA 510(k) clearance for the ENERGETIC HI-HUM AERSOL UNIT. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Energetic Pulmonary (Mchenry, US). The FDA issued a Cleared decision on May 9, 1983 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.

FDA 510(k) Submission Details - K831162

510(k) Number K831162 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1983
Decision Date May 09, 1983
Days to Decision 28 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
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 466
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K831162.
SINGLE USE NEBULIZER-ADJUST-AIR ENTRAIN
K834077 · Airlife, Inc. · Dec 1983
NEBULIZER ACCESSORY FOR SERVO VENTILL
K832898 · Siemens Elema AB · Nov 1983
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
AIRLIFE NEBULIZER HEATER
K821129 · Airlife, Inc. · May 1982
K831162 · ENERGETIC HI-HUM AERSOL UNIT
Download PDF Energetic Pulmonary