Cleared Special

K021439 - MODEL R1000 IR INSULIN PUMP, EZLINK SOFTWARE, SERMON SOFTWARE, R1000 IR DOWNLOAD CRADLE, AND SERIAL INTERFACE ADAPTOR DO

K021439 is an FDA 510(k) clearance for MODEL R1000 IR INSULIN PUMP, manufactured by Animas Corp.. The device is a Class 2 General Hospital device with product code LZG cleared through the Special 510(k) pathway after a 23-day FDA review.

K021439 · Animas Corp. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
23d
Days
Class 2
Risk

K021439 is an FDA 510(k) clearance for the MODEL R1000 IR INSULIN PUMP, EZLINK SOFTWARE, SERMON SOFTWARE, R1000 IR DOWNL.... Classified as Pump, Infusion, Insulin (product code LZG), Class II - Special Controls.

Submitted by Animas Corp. (Frazer, US). The FDA issued a Cleared decision on May 29, 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 - K021439

510(k) Number K021439 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2002
Decision Date May 29, 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.

LZG Device Classification - Class 2, Special Controls

Product Code LZG Pump, Infusion, Insulin
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 - LZG Pump, Infusion, Insulin

All 83
Devices cleared under the same product code (LZG) and FDA review panel - the closest regulatory comparables to K021439.
DISETRONIC D-TRON INSULIN INFUSION PUMP
K021725 · Disetronic Medical Systems AG · Aug 2002
DANA DIABECARE II INSULIN PUMP & SUPERLINE-EASYRELEASE, SOFT-RELEASE-ST, & SOFT-RELEASE-R INFUSION SETS
K022317 · Sooil Development Co., Ltd. · Aug 2002
GLUCOPRO EVO INFUSION PUMP
K013309 · Nipro Diabetes Systems, Inc. · Jun 2002
MICROJET QUARK, MODEL U100 OR U40
K013807 · Cane S.R.L. · Dec 2001
DANA DIABECARE
K001604 · Sooil Development Co., Ltd. · Aug 2000
R1000 SERIES INSULIN PUMP
K993184 · Animas Corp. · Feb 2000
K021439 · MODEL R1000 IR INSULIN PUMP, EZLINK SOFTWARE, SERMON SOFTWARE, R1000 IR DOWNLOAD CRADLE, AND SERIAL INTERFACE ADAPTOR DO
Download PDF FDA Summary Animas Corp.