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)
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.

View all Icu Medical, Inc. devices

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 53
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
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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
BACSTOP
K053405 · Elcam Medical Acal · May 2006