Cleared Traditional

K043261 - HARVEST GRAFT DELIVERY SYRINGE

K043261 is the FDA 510(k) clearance for HARVEST GRAFT DELIVERY SYRINGE by Harvest Technologies, Corp.. It is a Class 2 General Hospital device (product code FMF) cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K043261 · Harvest Technologies, Corp. · General Hospital
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Mar 2005
Decision
107d
Days
Class 2
Risk

K043261 is an FDA 510(k) clearance for the HARVEST GRAFT DELIVERY SYRINGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Harvest Technologies, Corp. (Plymouth, US). The FDA issued a Cleared decision on March 11, 2005 after a review of 107 days - within the typical 510(k) review window.

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: 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 Harvest Technologies, Corp. devices

Submission Details

510(k) Number K043261 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2004
Decision Date March 11, 2005
Days to Decision 107 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
22d faster than avg
Panel avg: 129d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 286
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K043261.
TERUMO SYRINGE WITH/WITHOUT NEEDLE
K052034 · Terumo Medical Corp. · Aug 2005
SYNTHES (USA) BONE MARROW ASPIRATION SYRINGE
K051720 · Synthes (Usa) · Jul 2005
STRYKER DISCMONITOR
K050753 · Stryker Instruments · May 2005
1BD SOLOSHOT IX SYRINGE
K042934 · Becton, Dickinson & CO · Oct 2004
SMITH & NEPHEW GRAFT DELIVERY SYSTEM
K041976 · Smith & Nephew, Inc. · Aug 2004
VASCULAR SOLUTIONS AUTO-FILL SYRINGE KIT
K033721 · Vascular Solutions, Inc. · Feb 2004