510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K912197Substantially Equivalent

Skin Saver(tm) Tubing Holder, Model 467

Alpine Specialties, Inc., Loveland CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K912197 is the FDA 510(k) clearance record for SKIN SAVER(TM) TUBING HOLDER, MODEL 467, a class I device, cleared for Alpine Specialties, Inc. on under FDA product code CAT (Cannula, Nasal, Oxygen). FDA records list 2 510(k) clearances for Alpine Specialties, Inc., from to . As of , FDA records show no recalls naming K912197.

Clearance record

Decision date
Received
(95 days to decision)
Product code
CAT Cannula, Nasal, Oxygen
Regulation
21 CFR 868.5340
Device class
Class I
Review panel
Anesthesiology
Applicant
Alpine Specialties, Inc. 640 E. Eisenhower, Loveland CO
510(k) summary
Statement
Third party review
No

Clearances, product code CAT

Trailing 12 months

FDA records hold no clearances under product code CAT in the trailing twelve months.

FDA records show no clearances under product code CAT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CAT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260