Cleared Special

K040633 - CLICK-ON (FDA 510(k) Clearance)

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

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

Submission Details

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

106d faster than avg

Panel avg: 128d · This submission: 22d

Pathway characteristics

Modification to existing cleared device.

Device Classification

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.