Cleared Traditional

K971808 - SPACE CHAMBER FOR MODEL NUMBER AND ACCESSORIES

K971808 is an FDA 510(k) clearance for SPACE CHAMBER FOR MODEL NUMBER AND ACCE..., manufactured by Monarch Medical. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K971808 · Monarch Medical · Anesthesiology device
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Sep 1997
Decision
134d
Days
Class 2
Risk

K971808 is an FDA 510(k) clearance for the SPACE CHAMBER FOR MODEL NUMBER AND ACCESSORIES. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Monarch Medical (Blaine, US). The FDA issued a Cleared decision on September 26, 1997 after a review of 134 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Monarch Medical devices

FDA 510(k) Submission Details - K971808

510(k) Number K971808 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1997
Decision Date September 26, 1997
Days to Decision 134 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 140d · This submission: 134d
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 K971808.
MODEL IRC 1199 SCOUT NEBULIZER
K973468 · Invacare Corp. · Dec 1997
ATOMISOR
K970844 · Medical Consulting Service, Inc. · Nov 1997
DEY VIAL SODIUM CHLORIDE 3%
K972778 · Dey Laboratories, Inc. · Oct 1997
SODIUM CHLORIDE INHALATION SOLUTION, USP
K972466 · Holopack International, LP · Aug 1997
STERILE WATER FOR INHALATION, USP
K972467 · Holopack International, LP · Aug 1997
ICEL ULTRASONIC NEBULIZER MODELS PU 12000 AIR AND PU 12300 AIR
K972371 · Brasamerica Medical Equipment, Inc. · Aug 1997