Cleared Abbreviated

K041344 - OPEN BORE SYRINGE (FDA 510(k) Clearance)

Class II General Hospital device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K041344 · Isotis NV · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2004
Decision
57d
Days
Class 2
Risk

K041344 is an FDA 510(k) clearance for the OPEN BORE SYRINGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Isotis NV (Bilthoven, NL). The FDA issued a Cleared decision on July 16, 2004 after a review of 57 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Isotis NV devices

Submission Details

510(k) Number K041344 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2004
Decision Date July 16, 2004
Days to Decision 57 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 128d · This submission: 57d
Pathway characteristics
Standards-based clearance path.

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 748
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K041344.
Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)
K252279 · Chirana T.Injecta,A.S. · Apr 2026
Profoject™ Insulin Syringes
K253068 · CMT Health PTE., Ltd. · Feb 2026
Instylla Delivery Kit
K253769 · Instylla, Inc. · Dec 2025
DuoprossTM Smart Cap (Type I)
K252518 · Duopross Meditech Corporate · Dec 2025
EXEL Disposable Syringe
K251089 · Exelint International, Co. · Dec 2025
Verisafe Safety Retractable Insulin Syringes
K250192 · Promisemed Hangzhou Meditech Co., Ltd. · Dec 2025