Cleared Abbreviated

SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE (K003571) - FDA 510(k) Clearance

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

K003571 · Terumo Medical Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
84d
Days
Class 2
Risk

K003571 is an FDA 510(k) clearance for the SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Terumo Medical Corp. (Elkton, US). The FDA issued a Cleared decision on February 12, 2001 after a review of 84 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 Terumo Medical Corp. devices

Submission Details

510(k) Number K003571 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2000
Decision Date February 12, 2001
Days to Decision 84 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 129d · This submission: 84d
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 241
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K003571.
PCCS GRAFT DELIVERY SYSTEM
K021071 · Biomet, Inc. · Jul 2002
DUPLOJECT EASY-PREP SYSTEM 1ML, 2ML, 5ML
K020666 · Baxter Healthcare Corp · Jun 2002
DUPLOREACH
K014088 · Baxter Healthcare Corp · Jun 2002
STERILE PISTON SYRINGE
K002717 · Abbott Laboratories · Jan 2001
DUPLOGRIP
K003193 · Baxter Healthcare Corp · Nov 2000
TISSOMAT AND SPRAY SET
K981089 · Baxter Healthcare Corp · Jul 2000