Cleared Traditional

K905838 - STRATO PORT INTRODUCER KT(10 FR) LPS 50...

K905838 is the FDA 510(k) clearance for STRATO PORT INTRODUCER KT(10 FR) LPS 50... by Strato Medical Corp.. It is a Class 2 Gastroenterology & Urology device (product code LJT) cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K905838 · Strato Medical Corp. · Gastroenterology & Urology device
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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
Combination Product No
PCCP Authorized No
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 122
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K905838.
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IPI IMPORT
K922419 · Pudenz-Schulte Medical Research Corp. · Nov 1992
PLASTIC ATTACHABLE DUAL PORT
K912702 · Davol, Inc. · Sep 1991
STRATO PORT INTRODUCER KT(10 FR) LPS 5013/MODIFIED
K905839 · Strato Medical Corp. · Apr 1991
STRATO PORT INTRODUCER KT(10 FR) LPS 5057/MODIFIED
K905840 · Strato Medical Corp. · Apr 1991
STRATO PORT INTRODUCER KT(12 FR) LPS 5200/MODIFIED
K905841 · Strato Medical Corp. · Apr 1991