Cleared Traditional

K092986 - ACACIA PISTON SYRINGE

K092986 is an FDA 510(k) clearance for ACACIA PISTON SYRINGE, manufactured by Acacia, Inc.. The device is a Class 2 General Hospital device with 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

FDA 510(k) Submission Details - K092986

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
Combination Product No
PCCP Authorized No
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.

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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FMF Syringe, Piston

All 429
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K092986.
GRAFT DELIVERY SYSTEM MODEL SA-6115
K100754 · Micromedics, Inc. · Jun 2010
EPIDRUM
K093863 · Exmoor Plastics , Ltd. · May 2010
COAXIAL APPLICATOR SYSTEM
K091722 · Biomet, Inc. · Mar 2010
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

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.