Cleared Special

K152362 - Terumo SurGuard 3 Safety Hypodermic Needle

K152362 is an FDA 510(k) clearance for Terumo SurGuard 3 Safety Hypodermic Needle, 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 57-day FDA review.

K152362 · Terumo (Philippines) Corporation · General Hospital
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Oct 2015
Decision
57d
Days
Class 2
Risk

K152362 is an FDA 510(k) clearance for the Terumo SurGuard 3 Safety Hypodermic Needle. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Terumo (Philippines) Corporation (Binan, PH). The FDA issued a Cleared decision on October 16, 2015 after a review of 57 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 - K152362

510(k) Number K152362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2015
Decision Date October 16, 2015
Days to Decision 57 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
72d faster than avg
Panel avg: 129d · This submission: 57d
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 Consultant

Terumo Medical Corporation
PHEBE VARGHESE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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