Cleared Traditional

K883964 - AIRLIFE MISTY NEB MEDICATION SYSTEM W/FILTER

K883964 is an FDA 510(k) clearance for AIRLIFE MISTY NEB MEDICATION SYSTEM W/F..., manufactured by Baxter Healthcare Corp. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K883964 · Baxter Healthcare Corp · Anesthesiology device
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Nov 1988
Decision
71d
Days
Class 2
Risk

K883964 is an FDA 510(k) clearance for the AIRLIFE MISTY NEB MEDICATION SYSTEM W/FILTER. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Valencia, US). The FDA issued a Cleared decision on November 30, 1988 after a review of 71 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 Baxter Healthcare Corp devices

FDA 510(k) Submission Details - K883964

510(k) Number K883964 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1988
Decision Date November 30, 1988
Days to Decision 71 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
69d faster than avg
Panel avg: 140d · This submission: 71d
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 367
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K883964.
NEBULIZER HEATER
K882935 · Automatic Liquid Packaging, Inc. · Dec 1988
UNIT DOSE 3% SODIUM CHLORIDE SOLUTION FOR INHALA.
K884359 · Automatic Liquid Packaging, Inc. · Dec 1988
OMRON ULTRASONIC NEBULIZER NE-U06
K875134 · Nidek, Inc. · Dec 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