Cleared Traditional

K972657 - ULTRAMIST 2000

K972657 is an FDA 510(k) clearance for ULTRAMIST 2000, manufactured by Texas Medical Industries, Inc.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K972657 · Texas Medical Industries, Inc. · Anesthesiology device
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Feb 1998
Decision
202d
Days
Class 2
Risk

K972657 is an FDA 510(k) clearance for the ULTRAMIST 2000. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Texas Medical Industries, Inc. (Royse City, US). The FDA issued a Cleared decision on February 2, 1998 after a review of 202 days - an extended review 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: 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 Texas Medical Industries, Inc. devices

FDA 510(k) Submission Details - K972657

510(k) Number K972657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1997
Decision Date February 02, 1998
Days to Decision 202 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
62d slower than avg
Panel avg: 140d · This submission: 202d
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 K972657.
HOPE NEBULIZER
K980407 · B&B Medical Technologies, Inc. · May 1998
STEALTH, METERED DOSE INHALER (MDI) SPACER WITHOUT INTEGRAL ACTUATOR
K973532 · Dhd Diemolding Healthcare Div. · Mar 1998
ULTRANEB
K974379 · Bremed Italia, S.R.L. · Feb 1998
0.9.% SODIUM CHLORIDE INHALATION SOLUTION, USP
K974056 · Holopack International, LP · Jan 1998
MODEL IRC 1199 SCOUT NEBULIZER
K973468 · Invacare Corp. · Dec 1997
ATOMISOR
K970844 · Medical Consulting Service, Inc. · Nov 1997