Cleared Traditional

K972467 - STERILE WATER FOR INHALATION, USP

K972467 is an FDA 510(k) clearance for STERILE WATER FOR INHALATION, manufactured by Holopack International, LP. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K972467 · Holopack International, LP · Anesthesiology device
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Aug 1997
Decision
58d
Days
Class 2
Risk

K972467 is an FDA 510(k) clearance for the STERILE WATER FOR INHALATION, USP. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Holopack International, LP (Columbia, US). The FDA issued a Cleared decision on August 28, 1997 after a review of 58 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 Holopack International, LP devices

FDA 510(k) Submission Details - K972467

510(k) Number K972467 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1997
Decision Date August 28, 1997
Days to Decision 58 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 140d · This submission: 58d
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 247
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K972467.
DEY VIAL SODIUM CHLORIDE 3%
K972778 · Dey Laboratories, Inc. · Oct 1997
SPACE CHAMBER FOR MODEL NUMBER AND ACCESSORIES
K971808 · Monarch Medical · Sep 1997
SODIUM CHLORIDE INHALATION SOLUTION, USP
K972466 · Holopack International, LP · Aug 1997
ICEL ULTRASONIC NEBULIZER MODELS PU 12000 AIR AND PU 12300 AIR
K972371 · Brasamerica Medical Equipment, Inc. · Aug 1997
MDILOG, MODEL MDC-511
K970344 · Medtrak Technologies, Inc. · Aug 1997
PORT-NEB
K971933 · Medic-Aid , Ltd. · Aug 1997