Cleared Traditional

K880473 - AERO-MIST NEBULIZER HEATER

K880473 is an FDA 510(k) clearance for AERO-MIST NEBULIZER HEATER, manufactured by Pegasus Research Corp.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K880473 · Pegasus Research Corp. · Anesthesiology device
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Mar 1988
Decision
56d
Days
Class 2
Risk

K880473 is an FDA 510(k) clearance for the AERO-MIST NEBULIZER HEATER. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Pegasus Research Corp. (Corona Del Mar, US). The FDA issued a Cleared decision on March 31, 1988 after a review of 56 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 Pegasus Research Corp. devices

FDA 510(k) Submission Details - K880473

510(k) Number K880473 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1988
Decision Date March 31, 1988
Days to Decision 56 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 140d · This submission: 56d
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 224
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K880473.
OMRON ULTRASONIC NEBULIZER NE-U06
K875134 · Nidek, Inc. · Dec 1988
AIRLIFE MISTY NEB MEDICATION SYSTEM W/FILTER
K883964 · Baxter Healthcare Corp · Nov 1988
MICROCIRRUS MEDICAL NEBULIZER
K881935 · Dhd Medical Products Div. Diemolding Corp. · Jun 1988
INSPIRON NEBULO BASIC EXTERNAL HEATER
K880304 · Intertech Resources, Inc. · Mar 1988
BRONCHODILATOR TEE - 9056 SERIES
K873521 · Boehringer Laboratories · Mar 1988
ASTHMAKIT
K874047 · Dhd Medical Products Div. Diemolding Corp. · Feb 1988