Cleared Traditional

K921496 - SKIN SAVER(TM) TUBING HOLDER, MODEL 1921 MODIFIED

K921496 is an FDA 510(k) clearance for SKIN SAVER(TM) TUBING HOLDER, manufactured by Alpine Specialties, Inc.. The device is a Class 1 Anesthesiology device with 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.

FDA 510(k) Submission Details - K921496

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.

CAT Device Classification - Class 1, General Controls

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

All 22
Devices cleared under the same product code (CAT) and FDA review panel - the closest regulatory comparables to K921496.
NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCI
K011125 · Hudson Respiratory Care, Inc. · Jun 2001
NASAL CANNULA
K935533 · Puritas Health Care, Inc. · Feb 1994
4 SURE TM NASAL OXYGEN CANNULA
K922397 · Boston Pacific Medical, Inc. · Mar 1993
CANNULA NASAL OXYGEN
K920573 · B & F Medical Products, Inc. · Aug 1992
SALTER LABS NEONATAL NASAL OXYGEN CANNULA
K911740 · Salter Labs · Jul 1991
KENDALL CURITY OXYGEN NASAL CANNULA
K892435 · The Kendal Co. · Jun 1989