Cleared Traditional

K912197 - SKIN SAVER(TM) TUBING HOLDER, MODEL 467

K912197 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 95-day FDA review.

K912197 · Alpine Specialties, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1991
Decision
95d
Days
Class 1
Risk

K912197 is an FDA 510(k) clearance for the SKIN SAVER(TM) TUBING HOLDER, MODEL 467. 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 20, 1991 after a review of 95 days - within the typical 510(k) review window.

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 - K912197

510(k) Number K912197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 1991
Decision Date August 20, 1991
Days to Decision 95 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
45d faster than avg
Panel avg: 140d · This submission: 95d
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 K912197.
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
OXYGEN CANNULA EAR WRAP (STYLE A)
K863431 · Salter Labs · Sep 1986