Cleared Traditional

STRATO PORT INTRODUCER KT(10 FR) LPS 5015/MODIFIED (K905838) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K905838 · Strato Medical Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1991
Decision
113d
Days
Class 2
Risk

K905838 is an FDA 510(k) clearance for the STRATO PORT INTRODUCER KT(10 FR) LPS 5015/MODIFIED. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Strato Medical Corp. (Beverly, US). The FDA issued a Cleared decision on April 19, 1991 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 880.5965 - the FDA gastroenterology and urology 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Strato Medical Corp. devices

Submission Details

510(k) Number K905838 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received December 27, 1990
Decision Date April 19, 1991
Days to Decision 113 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 130d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5965
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - LJT Port & Catheter, Implanted, Subcutaneous, Intravascular

All 42
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K905838.
DUAL SLIM PORT IMPLANTED PORT (0654970/0654940)
K964066 · C.R. Bard, Inc. · Mar 1997
VASCULAR ACCESS PORT KIT
K955587 · Boston Scientific Corp · Mar 1996
AUTO SUTURE* CHEMOSITE IMPLANTABLE DRUG DELIVERY SYSTEM**
K952748 · United States Surgical, A Division of Tyco Healthc · Aug 1995
MEDTRONIC CATHETER ACCESS PORT MODEL 8500
K873735 · Medtronic Vascular · Nov 1987
HICKMAN PLASTIC SUBCUTANEOUS PORT
K873213 · C.R. Bard, Inc. · Oct 1987
MEDIPORT II MODEL MP-DL VASCULAR ACCESS PORT
K870817 · C.R. Bard, Inc. · Jul 1987