Cleared Traditional

K092986 - ACACIA PISTON SYRINGE

K092986 is the FDA 510(k) clearance for ACACIA PISTON SYRINGE by Acacia, Inc.. It is a Class 2 General Hospital device (product code FMF) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K092986 · Acacia, Inc. · General Hospital
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Oct 2009
Decision
29d
Days
Class 2
Risk

K092986 is an FDA 510(k) clearance for the ACACIA PISTON SYRINGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Acacia, Inc. (Brea, US). The FDA issued a Cleared decision on October 27, 2009 after a review of 29 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 Acacia, Inc. devices

Submission Details

510(k) Number K092986 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2009
Decision Date October 27, 2009
Days to Decision 29 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 129d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 264
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K092986.
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MICROMYST APPLICATOR, MODEL 20-5000
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UNIVERSAL VIAL ACCESS SPIKE
K080989 · Icu Medical, Inc. · May 2008