Cleared Special

K020881 - MODIFICATION TO PERSONAL INFUSOR LOCAL PAIN MANAGEMENT PROCEDURAL KIT

K020881 is an FDA 510(k) clearance for MODIFICATION TO PERSONAL INFUSOR LOCAL ..., manufactured by Science Incorporated. The device is a Class 2 General Hospital device with product code FRN cleared through the Special 510(k) pathway after a 9-day FDA review.

K020881 · Science Incorporated · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2002
Decision
9d
Days
Class 2
Risk

K020881 is an FDA 510(k) clearance for the MODIFICATION TO PERSONAL INFUSOR LOCAL PAIN MANAGEMENT PROCEDURAL KIT. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Science Incorporated (Burnsville, US). The FDA issued a Cleared decision on March 27, 2002 after a review of 9 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.

View all Science Incorporated devices

FDA 510(k) Submission Details - K020881

510(k) Number K020881 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2002
Decision Date March 27, 2002
Days to Decision 9 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
120d faster than avg
Panel avg: 129d · This submission: 9d
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 528
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K020881.
PERFUSOR COMPACT WITH FM SYSTEM
K022575 · B.Braun Medical, Inc. · Aug 2002
ABBOTT PLUM A+3 MULTICHANNEL INFUSION PUMP, MODEL 12348
K021350 · Abbott Laboratories · May 2002
MODIFICATION TO DYONICS INTELIJET REUSABLE CANNULAS
K020947 · Smith & Nephew, Inc. · Apr 2002
PARAGON INFUSION SYSTEM
K020251 · I-Flow Corp. · Feb 2002
STRYKER PAINPUMP
K014091 · Stryker Corp. · Dec 2001
SIMPLICITY INFUSION RESERVOIR FOR USE TO INFUSE MEDICINE, INCLUDING INSULIN, FROM AN EXTERNAL INFUSION PUMP
K013767 · Sterling Medivations, Inc. · Dec 2001