Cleared Traditional

K831162 - ENERGETIC HI-HUM AERSOL UNIT

K831162 is the FDA 510(k) clearance for ENERGETIC HI-HUM AERSOL UNIT by Energetic Pulmonary. It is a Class 2 Anesthesiology device (product code CAF) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K831162 · Energetic Pulmonary · Anesthesiology device

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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.

View all Energetic Pulmonary devices

Submission Details

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.

Device Classification

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 105

Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K831162.

NEBULAIRE (IRC 1040) NEBULIZER PUMP

K851436 · Invacare Corp. · Jul 1985

VARIABLE NEBULIZER HEATER

K851074 · Travenol Laboratories, S.A. · Jun 1985

SINGLE USE NEBULIZER-ADJUST-AIR ENTRAIN

K834077 · Airlife, Inc. · Dec 1983

SINGLE USE NEBULIZER, ADJUST. AIR-

K830895 · Airlife, Inc. · Apr 1983

AIRLIFE NEBULIZER HEATER

K821129 · Airlife, Inc. · May 1982

MISTY NEBULIZER

K802477 · Airlife, Inc. · Oct 1980

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K831162

Energetic Pulmonary

Mchenry, IL · US

Regulatory profile

1 submissions 1 cleared

100% clearance rate · Active in Anesthesiology

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Sourced from FDA 510(k) public files . Updated monthly.

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