Cleared Traditional

ADVANTAGE SYRINGE (K941545) - FDA 510(k) Clearance

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

K941545 · Bd Becton Dickinson Vacutainer Systems Preanalytic · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1994
Decision
54d
Days
Class 2
Risk

K941545 is an FDA 510(k) clearance for the ADVANTAGE SYRINGE. 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 May 23, 1994 after a review of 54 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K941545 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1994
Decision Date May 23, 1994
Days to Decision 54 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
75d faster than avg
Panel avg: 129d · This submission: 54d
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 222
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K941545.
MEDSAVER SYRINGE
K941095 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1994
1ML LUER-LOK SYRINGE
K941562 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1994
BD MICRO FINE, ULTRA FINE, AND ALLERGY SYRINGE
K941657 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1994
MONOJECT(R) 6 CC SAFETY SYRINGE
K924511 · Sherwood Medical Co. · Jul 1993
ARGYLE TURKEL SAFETY THORACENTESIS PROC. TRAY
K930847 · Sherwood Medical Co. · Jul 1993
BECTON DICKINSON DISPOS. SYRINGES PLUNGER TIP MOD.
K930321 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1993