Cleared Traditional

STRATO/INFUSAID PERIPORT INFUSION SET 41770,41771 (K960391) - FDA 510(k) Clearance

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

K960391 · Strato/Infusaid, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1996
Decision
156d
Days
Class 2
Risk

K960391 is an FDA 510(k) clearance for the STRATO/INFUSAID PERIPORT INFUSION SET 41770,41771. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Strato/Infusaid, Inc. (Norwood, US). The FDA issued a Cleared decision on July 3, 1996 after a review of 156 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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

Submission Details

510(k) Number K960391 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1996
Decision Date July 03, 1996
Days to Decision 156 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
27d slower than avg
Panel avg: 129d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - FPA Set, Administration, Intravascular

All 234
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K960391.
SOLUTION ADMINISTRATION SET WITH 0.22 MICRON HIGH PRESSURE EXTENDED LIFE FILTER
K964850 · Baxter Healthcare Corp · Feb 1997
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K962893 · Baxter Healthcare Corp · Oct 1996
FLUID ADMINISTRATION SET - CONTRAST MANAGER
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HUBER NEEDLE EXTENSION SET WITH STANDARD Y-INJECTION SITE, INTERLINK Y-INJECTION SITE, INTERLINK T-INJECTION SITE
K961495 · Baxter Healthcare Corp · Jun 1996
CONTINUFLO SOLUTION SET/SECONDARY MEDICATION SET
K961225 · Baxter Healthcare Corp · Jun 1996
ENERGIZED CONTAINER SYSTEM (MODIFICATION)
K954283 · Abbott Laboratories · May 1996