Cleared Traditional

K070988 - SC PROFI FINE PEN NEEDLE, MODELS

Also marketed or referenced as:
5MM, 8MM, 12.7MM (28G, 29G, 30G, 31G)

K070988 is an FDA 510(k) clearance for SC PROFI FINE PEN NEEDLE, manufactured by Shinchang Medical Co., Ltd.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K070988 · Shinchang Medical Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
139d
Days
Class 2
Risk

K070988 is an FDA 510(k) clearance for the SC PROFI FINE PEN NEEDLE, MODELS. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Shinchang Medical Co., Ltd. (Salt Lake City, US). The FDA issued a Cleared decision on August 23, 2007 after a review of 139 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Shinchang Medical Co., Ltd. devices

FDA 510(k) Submission Details - K070988

510(k) Number K070988 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2007
Decision Date August 23, 2007
Days to Decision 139 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
10d slower than avg
Panel avg: 129d · This submission: 139d
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 361
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K070988.
STERICAN HYPODERMIC NEEDLES
K072247 · B.Braun Medical, Inc. · Nov 2007
GRIPPER MICRO NEEDLE
K072059 · Smiths Medical MD, Inc. · Nov 2007
ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT
K071998 · Arrow Intl., Inc. · Sep 2007
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
EZ-MIO STERNAL
K063567 · Vidacare Corporation · Jan 2007