Cleared Traditional

K895768 - EXEL SAFELET CATHETER

K895768 is the FDA 510(k) clearance for EXEL SAFELET CATHETER by Exel Intl.. It is a Class 2 General Hospital device (product code FOZ) cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K895768 · Exel Intl. · General Hospital
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Feb 1990
Decision
143d
Days
Class 2
Risk

K895768 is an FDA 510(k) clearance for the EXEL SAFELET CATHETER. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Exel Intl. (Culver City, US). The FDA issued a Cleared decision on February 16, 1990 after a review of 143 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5200 - 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 Exel Intl. devices

Submission Details

510(k) Number K895768 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1989
Decision Date February 16, 1990
Days to Decision 143 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
14d slower than avg
Panel avg: 129d · This submission: 143d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

All 243
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K895768.
CATHETER WITH GUIDEWIRE ASSEMBLY DEVICE
K900056 · Abbott Laboratories · Aug 1990
MULTICATH PLACEMENT KIT
K901640 · Vygon Corp. · Aug 1990
ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER
K900263 · Arrow Intl., Inc. · Jul 1990
OPTICALLY CLEAR RADIOPAQUE CATHETER
K893546 · Critikon Company, LLC · Nov 1989
PROLONG INTRAVASCULAR CATHETER
K893965 · Baxter Healthcare Corp · Sep 1989
TERUMO SURFLO(R) I.V. CATHETER
K891087 · Terumo Medical Corp. · Jun 1989