Cleared Special

K080989 - UNIVERSAL VIAL ACCESS SPIKE

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

K080989 · Icu Medical, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K080989

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.

FMF Device Classification - Class 2, Special Controls

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 754
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K080989.
WEIGAO EMPTY CARTRIDGE SYRINGE
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BIO-MED SOFT INSULIN SYRINGE: MODELS 1CC, 0.5CC, 0.3CC
K081547 · Bio-Med USA, Inc. · Sep 2008
SPECTRA-LOR, 10 ML PLASTIC LOSS OF RESISTANCE SYRINGE, L/S, SPECTRA-LOR, 10ML PLASTIC LOSS OF RESISTANCE SYRINGE L/L
K081524 · Spectra Medical Devices, Inc. · Jul 2008
CONFLUENT SURGICAL EXTENDED TIP APPLICATOR, MODEL 70-2008-008
K072790 · Confluent Surgical,Inc · Jan 2008
PATIENT SAFE SYRINGE
K072654 · Retractable Technologies, Inc. · Dec 2007
CONTROLLED DELIVERY FOR OSTEOPLASTY (CDO SYSTEM) AND GRAFT PREPARATION SYSTEM
K072330 · Biomet, Inc. · Dec 2007
K080989 · UNIVERSAL VIAL ACCESS SPIKE
Download PDF FDA Summary Icu Medical, Inc.