Cleared Traditional

K013234 - MICROJET CRONO

K013234 is an FDA 510(k) clearance for MICROJET CRONO, manufactured by Cane S.R.L.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K013234 · Cane S.R.L. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
211d
Days
Class 2
Risk

K013234 is an FDA 510(k) clearance for the MICROJET CRONO. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Cane S.R.L. (Deer Field, US). The FDA issued a Cleared decision on April 26, 2002 after a review of 211 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Cane S.R.L. devices

FDA 510(k) Submission Details - K013234

510(k) Number K013234 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2001
Decision Date April 26, 2002
Days to Decision 211 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
82d slower than avg
Panel avg: 129d · This submission: 211d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 535
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K013234.
MEDRAD CONTINUUM MR COMPATIBLE INFUSION SYSTEM
K021988 · Medrad, Inc. · Aug 2002
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