Cleared Traditional

K961973 - DHD ACE WITH MASK KIT

K961973 is an FDA 510(k) clearance for DHD ACE WITH MASK KIT, manufactured by Dhd Diemolding Healthcare Div.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K961973 · Dhd Diemolding Healthcare Div. · Anesthesiology device
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Aug 1996
Decision
87d
Days
Class 2
Risk

K961973 is an FDA 510(k) clearance for the DHD ACE WITH MASK KIT. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Dhd Diemolding Healthcare Div. (Canastota, US). The FDA issued a Cleared decision on August 15, 1996 after a review of 87 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 Dhd Diemolding Healthcare Div. devices

FDA 510(k) Submission Details - K961973

510(k) Number K961973 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1996
Decision Date August 15, 1996
Days to Decision 87 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
53d faster than avg
Panel avg: 140d · This submission: 87d
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 248
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K961973.
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SALTER LABS 8990 SERIES NEBULIZER
K962085 · Salter Labs · Aug 1996
BAXTER NEBULIZER CAP MODEL 2D0868
K962161 · Baxter Healthcare Corp · Aug 1996
SALTERLABS 8960 SERIES NEBULIZER (8960/8961/8966/8984)
K961476 · Salter Labs · Jul 1996
HIGH FLOW ADJUSTABLE ENTRAINMENT NEBULIZER
K955104 · Automatic Liquid Packaging, Inc. · Jun 1996