Cleared Traditional

K120420 - STERILE BLUNT FOR SINGLE USE

K120420 is an FDA 510(k) clearance for STERILE BLUNT FOR SINGLE USE, manufactured by Shanghai Double Dove Industrial Co., Ltd.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 251-day FDA review.

K120420 · Shanghai Double Dove Industrial Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2012
Decision
251d
Days
Class 2
Risk

K120420 is an FDA 510(k) clearance for the STERILE BLUNT FOR SINGLE USE. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Shanghai Double Dove Industrial Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on October 18, 2012 after a review of 251 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.

FDA 510(k) Submission Details - K120420

510(k) Number K120420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2012
Decision Date October 18, 2012
Days to Decision 251 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
122d slower than avg
Panel avg: 129d · This submission: 251d
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 633
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K120420.
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K122249 · Terumo (Philippines) Corporation · Aug 2012
COMFORT EZ
K121632 · Simple Diagnostics, Inc. · Aug 2012
SAFETY INFUSION SET
K121908 · Greiner Bio-One North America, Inc. · Jul 2012
K120420 · STERILE BLUNT FOR SINGLE USE
Download PDF FDA Summary Shanghai Double Dove …