Cleared Special

K072487 - FAST1 INTRAOSSEOUS INFUSION SYSTEM

K072487 is an FDA 510(k) clearance for FAST1 INTRAOSSEOUS INFUSION SYSTEM, manufactured by Pyng Medical Corp.. The device is a Class 2 General Hospital device with product code FMI cleared through the Special 510(k) pathway after a 162-day FDA review.

K072487 · Pyng Medical Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2008
Decision
162d
Days
Class 2
Risk

K072487 is an FDA 510(k) clearance for the FAST1 INTRAOSSEOUS INFUSION SYSTEM. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Pyng Medical Corp. (Richmond, B.C., CA). The FDA issued a Cleared decision on February 13, 2008 after a review of 162 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - 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 Pyng Medical Corp. devices

FDA 510(k) Submission Details - K072487

510(k) Number K072487 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2007
Decision Date February 13, 2008
Days to Decision 162 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
33d slower than avg
Panel avg: 129d · This submission: 162d
Pathway characteristics
Modification to existing cleared device.

FMI Device Classification - Class 2, Special Controls

Product Code FMI Needle, Hypodermic, Single Lumen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
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 - FMI Needle, Hypodermic, Single Lumen

All 315
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K072487.
BD ECLIPSE NEEDLE WITH SMARTSLIP TECHNOLOGY
K100209 · Becton, Dickinson & CO · Feb 2010
EZ-MIO DISTAL TIBIA, EZ-IO DISTAL TIBIA, VIDAPORT INTRAOSSEOUS INFUSION SYSTEM, EZ-IO
K091140 · Vidacare Corporation · Oct 2009
K-PACK II NEEDLE - 29G THIN WALL
K082820 · Terumo Europe N.V. · Oct 2008
HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE
K073188 · Smiths Medical Asd, Inc. · Feb 2008
STERICAN HYPODERMIC NEEDLES
K072247 · B.Braun Medical, Inc. · Nov 2007
GRIPPER MICRO NEEDLE
K072059 · Smiths Medical MD, Inc. · Nov 2007