Cleared Traditional

K921496 - SKIN SAVER(TM) TUBING HOLDER

K921496 is the FDA 510(k) clearance for SKIN SAVER(TM) TUBING HOLDER by Alpine Specialties, Inc.. It is a Class 1 Anesthesiology device (product code CAT) cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K921496 · Alpine Specialties, Inc. · Anesthesiology device
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Aug 1992
Decision
158d
Days
Class 1
Risk

K921496 is an FDA 510(k) clearance for the SKIN SAVER(TM) TUBING HOLDER, MODEL 1921 MODIFIED. Classified as Cannula, Nasal, Oxygen (product code CAT), Class I - General Controls.

Submitted by Alpine Specialties, Inc. (Loveland, US). The FDA issued a Cleared decision on August 14, 1992 after a review of 158 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5340 - 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 Alpine Specialties, Inc. devices

Submission Details

510(k) Number K921496 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1992
Decision Date August 14, 1992
Days to Decision 158 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
18d slower than avg
Panel avg: 140d · This submission: 158d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CAT Cannula, Nasal, Oxygen
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5340
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 - CAT Cannula, Nasal, Oxygen

Devices cleared under the same product code (CAT) and FDA review panel - the closest regulatory comparables to K921496.
ARGYLE NASAL CANNULA
K833127 · Sherwood Medical Co. · Nov 1983
CONPHAR NASAL OXYGEN CANNULA-STERILE
K791247 · Conphar, Inc. · Jul 1979
NASAL, OXYGEN, CANNULA
K790885 · Airlife, Inc. · May 1979
CANNULAS, DYNACOR'S NASAL OXYGEN
K790056 · Medline Industries, Inc. · Feb 1979
NASAL OXYGEN CANNULA, #017207
K771074 · C.R. Bard, Inc. · Aug 1977