Cleared Traditional

K895735 - DESERET MULTILUMEN SUBCLAVIAN CATHETER

K895735 is the FDA 510(k) clearance for DESERET MULTILUMEN SUBCLAVIAN CATHETER by Deseret Medical, Inc.. It is a Class 1 General Hospital device (product code LYY) cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K895735 · Deseret Medical, Inc. · General Hospital
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May 1990
Decision
233d
Days
Class 1
Risk

K895735 is an FDA 510(k) clearance for the DESERET MULTILUMEN SUBCLAVIAN CATHETER. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Deseret Medical, Inc. (Sandy, US). The FDA issued a Cleared decision on May 18, 1990 after a review of 233 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6250 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Deseret Medical, Inc. devices

Submission Details

510(k) Number K895735 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1989
Decision Date May 18, 1990
Days to Decision 233 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d slower than avg
Panel avg: 129d · This submission: 233d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LYY Latex Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Latex Patient Examination Glove Is A Disposable Device Made Of Natural Rubber Latex That May Or May Not Bear A Trace Amount Of Residual Powder, And Is Intended To Be Worn On The Hand For Medical Purposes To Provide A Barrier Against Potentially Infectious Materials And Other Contaminants.
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 - LYY Latex Patient Examination Glove

All 207
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K895735.
PATIENT EXAMINATION GLOVES
K905550 · Medical Device Inspection Co., Inc. · Dec 1990
PATIENT EXAM GLOVES (DUSTED W/USP STARCH POWDER)
K903107 · Ansell, Inc. · Aug 1990
PATIENT EXAM GLOVES (FINISH W/USP STARCH POWDER)
K903108 · Ansell, Inc. · Aug 1990
ANSELL DENTA GLOVES
K895660 · Ansell, Inc. · Jan 1990
PATIENT EXAMINATION GLOVES (LATEX)
K894022 · Baxter Healthcare Corp · Aug 1989
B-D PATIENT EXAMINATION GLOVES
K894280 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1989