Cleared Traditional

K962438 - MISTY OX TURBOHEATER

K962438 is an FDA 510(k) clearance for MISTY OX TURBOHEATER, manufactured by Vital Signs, Inc.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K962438 · Vital Signs, Inc. · Anesthesiology device
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Jan 1997
Decision
203d
Days
Class 2
Risk

K962438 is an FDA 510(k) clearance for the MISTY OX TURBOHEATER. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Vital Signs, Inc. (Orange, US). The FDA issued a Cleared decision on January 13, 1997 after a review of 203 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 Vital Signs, Inc. devices

FDA 510(k) Submission Details - K962438

510(k) Number K962438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1996
Decision Date January 13, 1997
Days to Decision 203 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
63d slower than avg
Panel avg: 140d · This submission: 203d
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 385
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K962438.
RESPIFLO/S
K962874 · Curtin & Associates International , Inc. · Feb 1997
HOLDEN-WALKER HUMIDIFIER-NEBULIZER KIT
K963917 · Holden Walker Corp. · Feb 1997
CPI MODEL 6240 50 PSI NEBULIZER COMPRESSOR
K964994 · Contemporary Products, Inc. · Feb 1997
3050 SPORT-NEB
K964078 · Medical Industries America, Inc. · Jan 1997
SIEMENS SERVO ULTRA NEBULIZER 345
K960854 · Pacesetter, Inc. · Dec 1996
HEART NEBULIZER #100609
K963910 · Vortran Medical Technology 1, Inc. · Dec 1996