Cleared Special

K052217 - CRONO SUPER PID

K052217 is an FDA 510(k) clearance for CRONO SUPER PID, 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 29-day FDA review.

K052217 · Cane S.R.L. · General Hospital
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Sep 2005
Decision
29d
Days
Class 2
Risk

K052217 is an FDA 510(k) clearance for the CRONO SUPER PID. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Cane S.R.L. (Rivoli-Cascine Vica (Torino), IT). The FDA issued a Cleared decision on September 13, 2005 after a review of 29 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 - K052217

510(k) Number K052217 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2005
Decision Date September 13, 2005
Days to Decision 29 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
100d faster than avg
Panel avg: 129d · This submission: 29d
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 K052217.
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