Cleared Special

K041545 - CONTACT DETACH

K041545 is an FDA 510(k) clearance for CONTACT DETACH, 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 21-day FDA review.

K041545 · Unomedical A/S · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2004
Decision
21d
Days
Class 2
Risk

K041545 is an FDA 510(k) clearance for the CONTACT DETACH. 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 June 30, 2004 after a review of 21 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 - K041545

510(k) Number K041545 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2004
Decision Date June 30, 2004
Days to Decision 21 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
108d faster than avg
Panel avg: 129d · This submission: 21d
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
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K041545.
TEGO NEEDLE FREE ACCESS ACCESS DEVICE
K040710 · Icu Medical, Inc. · Aug 2004
PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION, MODEL 5118
K041410 · Icu Medical, Inc. · Jul 2004
SPLIT SEPTUM INJECTION SITES
K041042 · Fresenius Medical Care North America · Jul 2004
TALON INFUSION SET, MODEL IP XXXX
K033290 · Icu Medical, Inc. · Apr 2004
MULTIPORT MANIFOLD SET WITH SWABABLE VALVES, MODEL 9900
K040385 · Quest Medical, Inc. · Apr 2004
CLC2000 CATHETER PATENCY DEVICE
K021692 · Icu Medical, Inc. · Dec 2003