Cleared Special

K122249 - TERUMO SURGUARD3 SAFETY NEEDLE & HYPODERMIC SYRINGE WITH SAFETY NEEDLE

K122249 is an FDA 510(k) clearance for TERUMO SURGUARD3 SAFETY NEEDLE & HYPODE..., manufactured by Terumo (Philippines) Corporation. The device is a Class 2 General Hospital device with product code FMI cleared through the Special 510(k) pathway after a 32-day FDA review.

K122249 · Terumo (Philippines) Corporation · General Hospital
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Aug 2012
Decision
32d
Days
Class 2
Risk

K122249 is an FDA 510(k) clearance for the TERUMO SURGUARD3 SAFETY NEEDLE & HYPODERMIC SYRINGE WITH SAFETY NEEDLE. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Terumo (Philippines) Corporation (Elkton, US). The FDA issued a Cleared decision on August 28, 2012 after a review of 32 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. 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Terumo (Philippines) Corporation devices

FDA 510(k) Submission Details - K122249

510(k) Number K122249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2012
Decision Date August 28, 2012
Days to Decision 32 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
97d faster than avg
Panel avg: 129d · This submission: 32d
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 534
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K122249.
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