Cleared Special

K040633 - CLICK-ON

K040633 is an FDA 510(k) clearance for CLICK-ON, manufactured by Unomedical A/S. The device is a Class 2 General Hospital device with product code FPA cleared through the Special 510(k) pathway after a 22-day FDA review.

K040633 · Unomedical A/S · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
22d
Days
Class 2
Risk

K040633 is an FDA 510(k) clearance for the CLICK-ON. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Unomedical A/S (Roskilde, DK). The FDA issued a Cleared decision on April 1, 2004 after a review of 22 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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 Unomedical A/S devices

FDA 510(k) Submission Details - K040633

510(k) Number K040633 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2004
Decision Date April 01, 2004
Days to Decision 22 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
107d faster than avg
Panel avg: 129d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

FPA Device Classification - Class 2, Special Controls

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - FPA Set, Administration, Intravascular

All 533
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