Cleared Traditional

VERSACATH(TM) SELECTALUMEN(TM) W/CONVERSION TRAY (K910565) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K910565 · Menlo Care, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1991
Decision
115d
Days
Class 2
Risk

K910565 is an FDA 510(k) clearance for the VERSACATH(TM) SELECTALUMEN(TM) W/CONVERSION TRAY. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Menlo Care, Inc. (Menlo Park, US). The FDA issued a Cleared decision on June 3, 1991 after a review of 115 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 Menlo Care, Inc. devices

Submission Details

510(k) Number K910565 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received February 08, 1991
Decision Date June 03, 1991
Days to Decision 115 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 faster than avg
Panel avg: 129d · This submission: 115d
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 110
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K910565.
PRN ADAPTER
K933467 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1994
SAFE-DWELL PLUS CENTRAL VENOUS CATHETER
K921270 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1992
E-Z SET/MINICATH INFUSION SETS
K920635 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1992
SPLIT-SECOND INTRODUCER
K902527 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1990
CATHETER WITH GUIDEWIRE ASSEMBLY DEVICE
K900056 · Abbott Laboratories · Aug 1990
PROLONG INTRAVASCULAR CATHETER
K893965 · Baxter Healthcare Corp · Sep 1989