Cleared Special

K041414 - CRONO AND CRONO, MODEL 30

K041414 is an FDA 510(k) clearance for CRONO AND CRONO, manufactured by Cane S.R.L.. The device is a Class 2 General Hospital device with product code FRN cleared through the Special 510(k) pathway after a 42-day FDA review.

K041414 · Cane S.R.L. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2004
Decision
42d
Days
Class 2
Risk

K041414 is an FDA 510(k) clearance for the CRONO AND CRONO, MODEL 30. 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 July 8, 2004 after a review of 42 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 - K041414

510(k) Number K041414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2004
Decision Date July 08, 2004
Days to Decision 42 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
87d faster than avg
Panel avg: 129d · This submission: 42d
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 728
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K041414.
SPECTRUM AND SPECTRUM WITH MASTER DRUG LIBRARY
K042121 · Sigma Intl. · Aug 2004
PLUM A+ INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE , AND PLUM A+3 INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
K042081 · Hospira, Inc. · Aug 2004
BAXTER INFUSOR SV (SMALL VOLUME)
K041738 · Baxter Healthcare Corporation · Jul 2004
MEDLEY SYSTEM WITH BAR CODE MODULE, MODEL 8600
K041241 · Alaris Medical Systems, Inc. · Jul 2004
HOSPIRA PHOENIX INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
K041550 · Abbott Laboratories · Jun 2004
COLLEAGUE VOLUMETRIC INFUSION PUMPS
K041191 · Baxter Healthcare Corp · Jun 2004
K041414 · CRONO AND CRONO, MODEL 30
Download PDF FDA Summary Cane S.R.L.