Cleared Traditional

K980580 - BECTON DICKINSON SYRINGES

K980580 is an FDA 510(k) clearance for BECTON DICKINSON SYRINGES, manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K980580 · Bd Becton Dickinson Vacutainer Systems Preanalytic · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1998
Decision
128d
Days
Class 2
Risk

K980580 is an FDA 510(k) clearance for the BECTON DICKINSON SYRINGES. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on June 25, 1998 after a review of 128 days - within the typical 510(k) review window.

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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

FDA 510(k) Submission Details - K980580

510(k) Number K980580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 1998
Decision Date June 25, 1998
Days to Decision 128 days
Submission Type Traditional
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
1d faster than avg
Panel avg: 129d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMF Device Classification - Class 2, Special Controls

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 315
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K980580.
MTI 1 ML SYRINGE
K991225 · Micro Therapeutics, Inc. · Jul 1999
MONOJECT INSULIN SYRINGE
K991758 · The Kendal Co. · Jun 1999
STERILE WATER FOR INJECTION PREFILLED SYRING (SWFIPS)
K972728 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1998
B-D PEN ULTRA
K981797 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1998
BECTON DICKINSON SYRINGE
K980987 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1998
TERUMO DISPOSABLE HYPODERMC SYRINGE
K980181 · Terumo Medical Corp. · Apr 1998