Cleared Traditional

OXY-TUBE

K852625 · Ashai Co. , Ltd. · Anesthesiology
Sep 1985
Decision
90d
Days
Class 1
Risk

About This 510(k) Submission

K852625 is an FDA 510(k) clearance for the OXY-TUBE, a Cannula, Nasal, Oxygen (Class I — General Controls, product code CAT), submitted by Ashai Co. , Ltd. (Australia, AU). The FDA issued a Cleared decision on September 18, 1985, 90 days after receiving the submission on June 20, 1985. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5340.

Submission Details

510(k) Number K852625 FDA.gov
FDA Decision Cleared SESE
Date Received June 20, 1985
Decision Date September 18, 1985
Days to Decision 90 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code CAT — Cannula, Nasal, Oxygen
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5340

Similar Devices — CAT Cannula, Nasal, Oxygen

All 41
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
SKIN SAVER(TM) TUBING HOLDER, MODEL 1921 MODIFIED
K921496 · Alpine Specialties, Inc. · Aug 1992
CANNULA NASAL OXYGEN
K920573 · B & F Medical Products, Inc. · Aug 1992
NASAL OXYGEN CANNULA, 81585, 81587 & 81589
K913421 · Specialty Packaging Producs, Inc. · Oct 1991