Cleared Special

K082836 - ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES

K082836 is an FDA 510(k) clearance for ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES, manufactured by Icu Medical, Inc.. The device is a Class 2 General Hospital device with product code FMG cleared through the Special 510(k) pathway after a 152-day FDA review.

K082836 · Icu Medical, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2009
Decision
152d
Days
Class 2
Risk

K082836 is an FDA 510(k) clearance for the ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES. Classified as Stopcock, I.v. Set (product code FMG), Class II - Special Controls.

Submitted by Icu Medical, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on February 25, 2009 after a review of 152 days - an extended review 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. Standard predicate reliance. 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 - K082836

510(k) Number K082836 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2008
Decision Date February 25, 2009
Days to Decision 152 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
23d slower than avg
Panel avg: 129d · This submission: 152d
Pathway characteristics
Modification to existing cleared device.

FMG Device Classification - Class 2, Special Controls

Product Code FMG Stopcock, I.v. Set
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 - FMG Stopcock, I.v. Set

All 75
Devices cleared under the same product code (FMG) and FDA review panel - the closest regulatory comparables to K082836.
DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MANIFOLD, PHP MANIFOLD
K123084 · Elcam Medical Acal · May 2013
LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO
K130245 · Baxter Healthcare Corp · Mar 2013
DUAL SYRINGE HOLDER
K082110 · Surgin Surgical Instrumentation, Inc. · Jun 2009
ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS)
K082106 · Elcam Medical Acal · Oct 2008
CLAVE STOPCOCK
K080077 · Icu Medical, Inc. · Feb 2008
SMARTSITE STOPCOCK
K071400 · Cardinal Health, Alaris Products · Dec 2007
K082836 · ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES
Download PDF FDA Summary Icu Medical, Inc.