Cleared Traditional

K120191 - PUSH-ON NEEDLE 30GX8MM

K120191 is an FDA 510(k) clearance for PUSH-ON NEEDLE 30GX8MM, manufactured by Scandinavian Health Limited. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K120191 · Scandinavian Health Limited · General Hospital
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May 2012
Decision
121d
Days
Class 2
Risk

K120191 is an FDA 510(k) clearance for the PUSH-ON NEEDLE 30GX8MM. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Scandinavian Health Limited (Taoyuan City, TW). The FDA issued a Cleared decision on May 23, 2012 after a review of 121 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 Scandinavian Health Limited devices

FDA 510(k) Submission Details - K120191

510(k) Number K120191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2012
Decision Date May 23, 2012
Days to Decision 121 days
Submission Type Traditional
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
8d faster than avg
Panel avg: 129d · This submission: 121d
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 536
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K120191.
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K113422 · Terumo (Philippines) Corporation · Mar 2012
SOL-M EXCHANGEABLE NEEDLES
K112777 · Sol-Milennium Medical, Inc. · Feb 2012