Cleared Traditional

K040439 - MDI TRIGGER GUARD

K040439 is an FDA 510(k) clearance for MDI TRIGGER GUARD, manufactured by North American Technical Services (Nats) Corp.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K040439 · North American Technical Services (Nats) Corp. · Anesthesiology device
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Jul 2004
Decision
140d
Days
Class 2
Risk

K040439 is an FDA 510(k) clearance for the MDI TRIGGER GUARD. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by North American Technical Services (Nats) Corp. (Sound Beach, US). The FDA issued a Cleared decision on July 8, 2004 after a review of 140 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 North American Technical Services (Nats) Corp. devices

FDA 510(k) Submission Details - K040439

510(k) Number K040439 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2004
Decision Date July 08, 2004
Days to Decision 140 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 140d · This submission: 140d
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 310
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K040439.
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OMNI~NEB
K030396 · B&B Medical Technologies, Inc. · May 2004