Cleared Traditional

K013807 - MICROJET QUARK, MODEL U100 OR U40

K013807 is an FDA 510(k) clearance for MICROJET QUARK, manufactured by Cane S.R.L.. The device is a Class 2 General Hospital device with product code LZG cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K013807 · Cane S.R.L. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2001
Decision
27d
Days
Class 2
Risk

K013807 is an FDA 510(k) clearance for the MICROJET QUARK, MODEL U100 OR U40. Classified as Pump, Infusion, Insulin (product code LZG), Class II - Special Controls.

Submitted by Cane S.R.L. (Deer Field, US). The FDA issued a Cleared decision on December 12, 2001 after a review of 27 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.

FDA 510(k) Submission Details - K013807

510(k) Number K013807 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2001
Decision Date December 12, 2001
Days to Decision 27 days
Submission Type Traditional
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
102d faster than avg
Panel avg: 129d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K013807.
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
MODEL R1000 IR INSULIN PUMP, EZLINK SOFTWARE, SERMON SOFTWARE, R1000 IR DOWNLOAD CRADLE, AND SERIAL INTERFACE ADAPTOR DO
K021439 · Animas Corp. · May 2002
DANA DIABECARE
K001604 · Sooil Development Co., Ltd. · Aug 2000
R1000 SERIES INSULIN PUMP
K993184 · Animas Corp. · Feb 2000
DISETRONIC D-TRON INSULIN INFUSION PUMP
K994186 · Disetronic Medical Systems · Dec 1999
K013807 · MICROJET QUARK, MODEL U100 OR U40
Download PDF FDA Summary Cane S.R.L.