Cleared Traditional

K112475 - XTRACT SYRINGE KEY SYSTEM

K112475 is an FDA 510(k) clearance for XTRACT SYRINGE KEY SYSTEM, manufactured by Xtract Solutions. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K112475 · Xtract Solutions · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2011
Decision
73d
Days
Class 2
Risk

K112475 is an FDA 510(k) clearance for the XTRACT SYRINGE KEY SYSTEM. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Xtract Solutions (Portland, US). The FDA issued a Cleared decision on November 10, 2011 after a review of 73 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.

FDA 510(k) Submission Details - K112475

510(k) Number K112475 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2011
Decision Date November 10, 2011
Days to Decision 73 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
56d faster than avg
Panel avg: 129d · This submission: 73d
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 638
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K112475.
SHIFENG DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE
K111841 · Chengdu Xinjin Shifeng Med Appratus Inst Co., Ltd. · Mar 2012
KDL SYRINGES AND NEEDLE
K112057 · Shanghai Kindly Enterprise Dev. Group Co., · Dec 2011
BD EMERALD SINGLE USE, HYPODERMIC SYRINGE
K113241 · Becton Dickinson · Nov 2011
SYRINGES AND NEEDLES
K113091 · Jiangyin Caina Technology Co., Ltd. · Oct 2011
IMC INSULIN SYRINGE
K110882 · International Medsurg Connection · Aug 2011
INFILL GRAFT DELIVERY SYSTEM
K111632 · Pinnacle Spine Group, LLC · Aug 2011
K112475 · XTRACT SYRINGE KEY SYSTEM
Download PDF FDA Summary Xtract Solutions