Cleared Traditional

K090929 - STERILE HYPODERMIC SYRINGE AND NEEDLE FOR SINGLE USE, STERILE INSULING SYRINGE FOR SINGLE USE WITH FIXED NEEDLE

K090929 is an FDA 510(k) clearance for STERILE HYPODERMIC SYRINGE AND NEEDLE F..., manufactured by Shanghai Double Dove Industrial Co., Ltd.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K090929 · Shanghai Double Dove Industrial Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2009
Decision
71d
Days
Class 2
Risk

K090929 is an FDA 510(k) clearance for the STERILE HYPODERMIC SYRINGE AND NEEDLE FOR SINGLE USE, STERILE INSULING SYRING.... Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Shanghai Double Dove Industrial Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on June 12, 2009 after a review of 71 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Shanghai Double Dove Industrial Co., Ltd. devices

FDA 510(k) Submission Details - K090929

510(k) Number K090929 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2009
Decision Date June 12, 2009
Days to Decision 71 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
58d faster than avg
Panel avg: 129d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMF Device Classification - Class 2, Special Controls

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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 - FMF Syringe, Piston

All 378
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K090929.
ACACIA PISTON SYRINGE
K092986 · Acacia, Inc. · Oct 2009
NIPRO DISPOSABLE SYRINGE
K091279 · Nipro Medical Corporation · Aug 2009
BD FLU+ SYRINGE
K091377 · Becton, Dickinson & CO · Jul 2009
TERUMO SYRINGE WITH/WITHOUT NEEDLE
K083514 · Terumo Europe N.V. · May 2009
MICROMYST APPLICATOR, MODEL 20-5000
K082454 · Covidien · Nov 2008
UNIVERSAL VIAL ACCESS SPIKE
K080989 · Icu Medical, Inc. · May 2008