Cleared Traditional

SOLOPAK PARAGON INFUSOR PUMP AND INFUSION SET (K963355) - FDA 510(k) Clearance

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

K963355 · Solopak Medical Products, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1996
Decision
39d
Days
Class 2
Risk

K963355 is an FDA 510(k) clearance for the SOLOPAK PARAGON INFUSOR PUMP AND INFUSION SET. Classified as Pump, Infusion, Elastomeric (product code MEB), Class II - Special Controls.

Submitted by Solopak Medical Products, Inc. (Libertyville, US). The FDA issued a Cleared decision on October 4, 1996 after a review of 39 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Solopak Medical Products, Inc. devices

Submission Details

510(k) Number K963355 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1996
Decision Date October 04, 1996
Days to Decision 39 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
90d faster than avg
Panel avg: 129d · This submission: 39d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MEB Pump, Infusion, Elastomeric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 - MEB Pump, Infusion, Elastomeric

All 14
Devices cleared under the same product code (MEB) and FDA review panel - the closest regulatory comparables to K963355.
DISPOSABLE INFUSION PUMP KIT
K993972 · Biomet, Inc. · Feb 2000
SINGLEDAY INFUSOR 2 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL, INFUSOR SV 5 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL CY
K982102 · Baxter Healthcare Corp · Sep 1998
ONE-DAY/FIVE-DAY/SEVEN-DAY SYRINGE MATE
K971168 · Baxter Healthcare Corp · Jul 1997
INTERMATE XLV ELASTOMERIC INFUSION SYSTEM
K943664 · Baxter Healthcare Corp · Nov 1994
INTERMATE(R) LV ELASTOMERIC INFUSION DEVICE
K922382 · Baxter Healthcare Corp · Feb 1993