Cleared Special

K020947 - MODIFICATION TO DYONICS INTELIJET REUSABLE CANNULAS

K020947 is an FDA 510(k) clearance for MODIFICATION TO DYONICS INTELIJET REUSA..., manufactured by Smith & Nephew, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Special 510(k) pathway after a 23-day FDA review.

K020947 · Smith & Nephew, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
23d
Days
Class 2
Risk

K020947 is an FDA 510(k) clearance for the MODIFICATION TO DYONICS INTELIJET REUSABLE CANNULAS. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Andover, US). The FDA issued a Cleared decision on April 17, 2002 after a review of 23 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K020947

510(k) Number K020947 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2002
Decision Date April 17, 2002
Days to Decision 23 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 129d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

FRN Device Classification - Class 2, Special Controls

Product Code FRN Pump, Infusion
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 - FRN Pump, Infusion

All 848
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K020947.
MICROJET CRONO H
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MICROJET CRONO
K013234 · Cane S.R.L. · Apr 2002
MICROJET MODEL # CD4 AND CD4/20
K013776 · Cane S.R.I. · Apr 2002
MODIFICATION TO PERSONAL INFUSOR LOCAL PAIN MANAGEMENT PROCEDURAL KIT
K020881 · Science Incorporated · Mar 2002
PARAGON INFUSION SYSTEM
K020251 · I-Flow Corp. · Feb 2002
STRYKER PAINPUMP
K014091 · Stryker Corp. · Dec 2001
K020947 · MODIFICATION TO DYONICS INTELIJET REUSABLE CANNULAS
Download PDF FDA Summary Smith & Nephew, Inc.