Cleared Traditional

K895735 - DESERET MULTILUMEN SUBCLAVIAN CATHETER

K895735 is an FDA 510(k) clearance for DESERET MULTILUMEN SUBCLAVIAN CATHETER, manufactured by Deseret Medical, Inc.. The device is a Class 1 General Hospital device with 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

FDA 510(k) Submission Details - K895735

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
104d slower than avg
Panel avg: 129d · This submission: 233d
Pathway characteristics
Predicate-based equivalence.

LYY Device Classification - Class 1, General Controls

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 669
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K895735.
ALADAN TRI-CLEAN 110 POWDERLESS LATEX GLOVE
K902565 · Aladan Corp. · Jul 1990
MODIFIED NON-STERILE LATEX EXAMINATION GLOVES
K902181 · Aladan Corp. · Jun 1990
MODIFIED STERILE LATEX EXAMINATION GLOVES
K902182 · Aladan Corp. · Jun 1990
STERILE LATEX EXAMINATION GLOVE
K900868 · Sri Johani Sdn. Bhd. · Mar 1990
NON-STERILE LATEX PROCEDURE GLOVE
K900869 · Sri Johani Sdn. Bhd. · Mar 1990
UMI BRAIDED CATHETER CONNECTOR
K897128 · Universal Medical Instrument Corp. · Mar 1990