Cleared Abbreviated

ASPIREX - BONE MARROW ASPIRATE KIT (K041991) - FDA 510(k) Clearance

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

K041991 · Isotis Orthobiologics, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2004
Decision
55d
Days
Class 2
Risk

K041991 is an FDA 510(k) clearance for the ASPIREX - BONE MARROW ASPIRATE KIT. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Isotis Orthobiologics, Inc. (Irvine, US). The FDA issued a Cleared decision on September 16, 2004 after a review of 55 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 Orthobiologics, Inc. devices

Submission Details

510(k) Number K041991 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2004
Decision Date September 16, 2004
Days to Decision 55 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
74d faster than avg
Panel avg: 129d · This submission: 55d
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 209
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K041991.
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MERIT MEDICAL 1-ML SYRINGE
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BD INSULIN SYRINGE
K024112 · Becton, Dickinson & CO · Jan 2003