Cleared Traditional

CLIP-ON SPACER 20% (K041084) - FDA 510(k) Clearance

Also marketed or referenced as:
40% 50%

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K041084 · Serono, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2004
Decision
80d
Days
Class 2
Risk

K041084 is an FDA 510(k) clearance for the CLIP-ON SPACER 20%. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Serono, Inc. (Rockland, US). The FDA issued a Cleared decision on July 15, 2004 after a review of 80 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 Serono, Inc. devices

Submission Details

510(k) Number K041084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2004
Decision Date July 15, 2004
Days to Decision 80 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 129d · This submission: 80d
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 209
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K041084.
SYNTHES (USA) BONE MARROW ASPIRATION SYRINGE
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1BD SOLOSHOT IX SYRINGE
K042934 · Becton, Dickinson & CO · Oct 2004
SMITH & NEPHEW GRAFT DELIVERY SYSTEM
K041976 · Smith & Nephew, Inc. · Aug 2004
MERIT MEDICAL 1-ML SYRINGE
K024052 · Merit Medical Systems, Inc. · Feb 2003
BD INSULIN SYRINGE
K024112 · Becton, Dickinson & CO · Jan 2003
BONE GRAFT SYRINGE, MODEL 8600-00X0
K023088 · Wrightmedicaltechnologyinc · Oct 2002