Cleared Traditional

K051720 - SYNTHES (USA) BONE MARROW ASPIRATION SY...

K051720 is the FDA 510(k) clearance for SYNTHES (USA) BONE MARROW ASPIRATION SY... by Synthes (Usa). It is a Class 2 General Hospital device (product code FMF) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K051720 · Synthes (Usa) · General Hospital
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Optimized for regulatory review, auditing and printing
Jul 2005
Decision
28d
Days
Class 2
Risk

K051720 is an FDA 510(k) clearance for the SYNTHES (USA) BONE MARROW ASPIRATION SYRINGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Synthes (Usa) (West Chester, US). The FDA issued a Cleared decision on July 25, 2005 after a review of 28 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 Synthes (Usa) devices

Submission Details

510(k) Number K051720 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2005
Decision Date July 25, 2005
Days to Decision 28 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
101d faster than avg
Panel avg: 129d · This submission: 28d
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 287
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K051720.
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TERUMO SYRINGE WITH/WITHOUT NEEDLE
K052034 · Terumo Medical Corp. · Aug 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