Cleared Traditional

K964956 - E-Z SPACER MASK (SMALL)

K964956 is an FDA 510(k) clearance for E-Z SPACER MASK (SMALL), manufactured by Airpharma, LLC. The device is a Class 1 Anesthesiology device with product code CCQ cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K964956 · Airpharma, LLC · Anesthesiology device
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Apr 1997
Decision
133d
Days
Class 1
Risk

K964956 is an FDA 510(k) clearance for the E-Z SPACER MASK (SMALL). Classified as Nebulizer, Medicinal, Non-ventilatory (atomizer) (product code CCQ), Class I - General Controls.

Submitted by Airpharma, LLC (Ramona, US). The FDA issued a Cleared decision on April 23, 1997 after a review of 133 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5640 - 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 Airpharma, LLC devices

FDA 510(k) Submission Details - K964956

510(k) Number K964956 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1996
Decision Date April 23, 1997
Days to Decision 133 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 140d · This submission: 133d
Pathway characteristics
Predicate-based equivalence.

CCQ Device Classification - Class 1, General Controls

Product Code CCQ Nebulizer, Medicinal, Non-ventilatory (atomizer)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5640
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CCQ Nebulizer, Medicinal, Non-ventilatory (atomizer)

All 27
Devices cleared under the same product code (CCQ) and FDA review panel - the closest regulatory comparables to K964956.
EZ SPRAY
K972397 · Intertex Research, Inc. · Sep 1997
MDI TUTOR
K961894 · Mdi Tutor, Inc. · Aug 1996
MEDSHIELD/AEROCHAMBER
K961455 · Diemolding Corp. · Jul 1996
SMARTMIST ASTHMA MANAGMENT SYSTEM, SMARTMIST, MODEL NUMBER SM-100/SMARTMIST SPIROMETRY AIRWAY, MODEL NUMBER SA-100
K960593 · Aradigm Corp. · May 1996
SALINE SOLUTION- STERILE
K922033 · Trinity Laboratories, Inc. · Jul 1992
MODIFIED AEROCHAMBER WITH MASK
K900576 · Monaghan Medical Corp. · May 1991