Cleared Traditional

PENTAFERTE SINGLE USE SYRINGES, MODEL SIZE=VARIOUS SIZES (K002381) - FDA 510(k) Clearance

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

K002381 · Pentaferte, S.R.L. · General Hospital
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Jan 2001
Decision
160d
Days
Class 2
Risk

K002381 is an FDA 510(k) clearance for the PENTAFERTE SINGLE USE SYRINGES, MODEL SIZE=VARIOUS SIZES. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Pentaferte, S.R.L. (Campli (Teramo), IT). The FDA issued a Cleared decision on January 11, 2001 after a review of 160 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Pentaferte, S.R.L. devices

Submission Details

510(k) Number K002381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2000
Decision Date January 11, 2001
Days to Decision 160 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
31d slower than avg
Panel avg: 129d · This submission: 160d
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 K002381.
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