Cleared Special

K080989 - UNIVERSAL VIAL ACCESS SPIKE

K080989 is the FDA 510(k) clearance for UNIVERSAL VIAL ACCESS SPIKE by Icu Medical, Inc.. It is a Class 2 General Hospital device (product code FMF) cleared through the Special 510(k) pathway after a 25-day FDA review.

K080989 · Icu Medical, Inc. · General Hospital
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May 2008
Decision
25d
Days
Class 2
Risk

K080989 is an FDA 510(k) clearance for the UNIVERSAL VIAL ACCESS SPIKE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Icu Medical, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on May 2, 2008 after a review of 25 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - 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 Icu Medical, Inc. devices

Submission Details

510(k) Number K080989 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2008
Decision Date May 02, 2008
Days to Decision 25 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 129d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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 - FMF Syringe, Piston

All 280
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K080989.
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CONTROLLED DELIVERY FOR OSTEOPLASTY (CDO SYSTEM) AND GRAFT PREPARATION SYSTEM
K072330 · Biomet, Inc. · Dec 2007
ICU MEDICAL SINGLE-USE SYRINGE
K070856 · Icu Medical, Inc. · Oct 2007
SMALL VOLUME SYRINGE
K062865 · Alcon Laboratories · Aug 2007