Cleared Special

K042085 - CRONO F

K042085 is an FDA 510(k) clearance for CRONO F, 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 45-day FDA review.

K042085 · Cane S.R.L. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2004
Decision
45d
Days
Class 2
Risk

K042085 is an FDA 510(k) clearance for the CRONO F. 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 September 17, 2004 after a review of 45 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 Cane S.R.L. devices

FDA 510(k) Submission Details - K042085

510(k) Number K042085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2004
Decision Date September 17, 2004
Days to Decision 45 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
84d faster than avg
Panel avg: 129d · This submission: 45d
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 535
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K042085.
PAINPUMP1
K042405 · Stryker Corp. · Oct 2004
HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE
K042609 · Hospira, Inc. · Oct 2004
E-PAIN CARE
K041714 · Breg, Inc. · Oct 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