Cleared Traditional

K962084 - OMNICAN SYRINGE

K962084 is an FDA 510(k) clearance for OMNICAN SYRINGE, manufactured by B. Braun Medical AG. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 257-day FDA review.

K962084 · B. Braun Medical AG · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
257d
Days
Class 2
Risk

K962084 is an FDA 510(k) clearance for the OMNICAN SYRINGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by B. Braun Medical AG (Bethlehem, US). The FDA issued a Cleared decision on February 10, 1997 after a review of 257 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 B. Braun Medical AG devices

FDA 510(k) Submission Details - K962084

510(k) Number K962084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 1996
Decision Date February 10, 1997
Days to Decision 257 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
128d slower than avg
Panel avg: 129d · This submission: 257d
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 316
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K962084.
BECTON DICKINSON SYRINGE
K980987 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1998
TERUMO DISPOSABLE HYPODERMC SYRINGE
K980181 · Terumo Medical Corp. · Apr 1998
B-D E ML PEN
K980755 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1998
DRESSING CHANGE TRAYS
K963260 · Busse Hospital Disposables, Inc. · Nov 1996
TERUMO RETRACTABLE NEEDLE (RN) SYRINGE
K953940 · Terumo Medical Corp. · May 1996
BECTON DICKINSON SYRINGSE
K954064 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1995