Cleared Traditional

K063142 - MANUAL PD-IO

Also marketed or referenced as:
POWERED PD-IO

K063142 is an FDA 510(k) clearance for MANUAL PD-IO, manufactured by Vidacare Corporation. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K063142 · Vidacare Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2006
Decision
53d
Days
Class 2
Risk

K063142 is an FDA 510(k) clearance for the MANUAL PD-IO. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Vidacare Corporation (Irvine, US). The FDA issued a Cleared decision on December 8, 2006 after a review of 53 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Vidacare Corporation devices

FDA 510(k) Submission Details - K063142

510(k) Number K063142 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 2006
Decision Date December 08, 2006
Days to Decision 53 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 129d · This submission: 53d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 264
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K063142.
HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE, HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE WITH SYRINGE
K071785 · Smiths Medical Asd, Inc. · Aug 2007
BD HYPOINT NEEDLE
K070440 · Becton, Dickinson & CO · Mar 2007
PORTEX HYPODERMIC NEEDLE- PRO EDGE SAFETY DEVICE, 18GX1, 401810, 19GX1, 401910, 20GX1,402010, 21GX1402110
K063450 · Smiths Medical Asd, Inc. · Jan 2007
MEDLINE HYPODERMIC NEEDLES
K062984 · Medline Industries, Inc. · Nov 2006
29G AND 30G K-PACK II NEEDLE
K062608 · Terumo Europe N.V. · Sep 2006
BUSSE HOSPITAL DISPOSABLES NEEDLE STICK BLOCK/CUBE
K052843 · Busse Hospital Disposables, Inc. · Apr 2006