Cleared Traditional

K121607 - TERUMO NEEDLE

K121607 is the FDA 510(k) clearance for TERUMO NEEDLE by Terumo (Philippines) Corporation. It is a Class 2 General Hospital device (product code FMI) cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K121607 · Terumo (Philippines) Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2012
Decision
160d
Days
Class 2
Risk

K121607 is an FDA 510(k) clearance for the TERUMO(R) 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 November 8, 2012 after a review of 160 days - an extended review 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: 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 Terumo (Philippines) Corporation devices

Submission Details

510(k) Number K121607 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2012
Decision Date November 08, 2012
Days to Decision 160 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
31d slower than avg
Panel avg: 129d · This submission: 160d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 249
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K121607.
STERICAN CANNULA
K131842 · B.Braun Medical, Inc. · Aug 2013
BD PEN NEEDLE
K131358 · Becton, Dickinson & CO · Jul 2013
BD PEN NEEDLE
K123300 · Becton, Dickinson & CO · Jan 2013
NIPRO HUBER INFUSION, EXCEL HUBER NEEDLE
K113469 · Nipro Medical Corporation · Oct 2012
BD AUTOSHIELD DUO PEN NEEDLE
K110703 · Becton, Dickinson and Company · Jul 2011
BD ECLIPSE NEEDLE WITH SMARTSLIP TECHNOLOGY
K100209 · Becton, Dickinson & CO · Feb 2010