Cleared Traditional

K897128 - UMI BRAIDED CATHETER CONNECTOR

K897128 is an FDA 510(k) clearance for UMI BRAIDED CATHETER CONNECTOR, manufactured by Universal Medical Instrument Corp.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K897128 · Universal Medical Instrument Corp. · General Hospital
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Mar 1990
Decision
65d
Days
Class 1
Risk

K897128 is an FDA 510(k) clearance for the UMI BRAIDED CATHETER CONNECTOR. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Universal Medical Instrument Corp. (Ballston Spa, US). The FDA issued a Cleared decision on March 1, 1990 after a review of 65 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Universal Medical Instrument Corp. devices

FDA 510(k) Submission Details - K897128

510(k) Number K897128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1989
Decision Date March 01, 1990
Days to Decision 65 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
64d faster than avg
Panel avg: 129d · This submission: 65d
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 654
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K897128.
DESERET MULTILUMEN SUBCLAVIAN CATHETER
K895735 · Deseret Medical, Inc. · May 1990
STERILE LATEX EXAMINATION GLOVE
K900868 · Sri Johani Sdn. Bhd. · Mar 1990
NON-STERILE LATEX PROCEDURE GLOVE
K900869 · Sri Johani Sdn. Bhd. · Mar 1990
POWDER-FREE VINYL EXAMINATION GLOVES
K894686 · Dynarex Corp. · Jan 1990
CLP ELEVATED LIPID CONTROL
K895858 · Creative Laboratory Products, Inc. · Jan 1990
ANSELL DENTA GLOVES
K895660 · Ansell, Inc. · Jan 1990