Cleared Traditional

K953254 - STRATO/INFUSAID INFUSE-A-KIT

K953254 is an FDA 510(k) clearance for STRATO/INFUSAID INFUSE-A-KIT, manufactured by Strato/Infusaid, Inc.. The device is a Class 2 General Hospital device with product code LJT cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K953254 · Strato/Infusaid, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1995
Decision
140d
Days
Class 2
Risk

K953254 is an FDA 510(k) clearance for the STRATO/INFUSAID INFUSE-A-KIT. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Strato/Infusaid, Inc. (Norwood, US). The FDA issued a Cleared decision on November 29, 1995 after a review of 140 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5965 - 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 Strato/Infusaid, Inc. devices

FDA 510(k) Submission Details - K953254

510(k) Number K953254 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received July 12, 1995
Decision Date November 29, 1995
Days to Decision 140 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 129d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LJT Device Classification - Class 2, Special Controls

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 General Hospital devices follow this clearance model.

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

All 236
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K953254.
PORT-A-CATH DUAL LUMEN IMPLANTABLE VENOUS
K955407 · Sims Deltec, Inc. · Feb 1996
STRATO/INFUSAID LIFE & INFUSE-A-PORT IMPLANTABLE PORT SYSTEM
K953529 · Strato/Infusaid, Inc. · Jan 1996
CELSITE VENOUS ACCESS SYSTEM OTW
K954297 · B.Braun Medical, Inc. · Dec 1995
SIMS SILO NEEDLE DE-ACCESS ENCLOSURE
K935767 · Sims Deltec, Inc. · Nov 1995
VASPORT DUAL LUMEN VASCULAR ACCESS SYSTEM
K954433 · Gish Biomedical, Inc. · Nov 1995
VASPORT VASCULAR ACCESS PORT
K953571 · Gish Biomedical, Inc. · Oct 1995