Cleared Traditional

K895768 - EXEL SAFELET CATHETER

K895768 is an FDA 510(k) clearance for EXEL SAFELET CATHETER, manufactured by Exel Intl.. The device is a Class 2 General Hospital device with 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

FDA 510(k) Submission Details - K895768

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
Combination Product No
PCCP Authorized No
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.

FOZ Device Classification - Class 2, Special Controls

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 405
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K895768.
GESCO DUAL LUMEN PER-Q-CATH-DL
K895942 · Gesco Intl., Inc. · Jul 1990
DESERET OPTIMA INTRAVASCULAR CATHETER
K900116 · Deseret Medical, Inc. · Jun 1990
DESERET INTRAVASCULAR CATHETER
K895734 · Deseret Medical, Inc. · Apr 1990
STREAMLINE VASCULAR ACCESS DEVICE
K896774 · Menlo Care, Inc. · Dec 1989
OPTICALLY CLEAR RADIOPAQUE CATHETER
K893546 · Critikon Company, LLC · Nov 1989
PROLONG INTRAVASCULAR CATHETER
K893965 · Baxter Healthcare Corp · Sep 1989