Cleared Traditional

K834165 - SYRINGE

K834165 is an FDA 510(k) clearance for SYRINGE, manufactured by Elfa Trading Co.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K834165 · Elfa Trading Co. · General Hospital
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Dec 1983
Decision
12d
Days
Class 2
Risk

K834165 is an FDA 510(k) clearance for the SYRINGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Elfa Trading Co. (Walker, US). The FDA issued a Cleared decision on December 13, 1983 after a review of 12 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 Elfa Trading Co. devices

FDA 510(k) Submission Details - K834165

510(k) Number K834165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1983
Decision Date December 13, 1983
Days to Decision 12 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
117d faster than avg
Panel avg: 129d · This submission: 12d
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 544
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K834165.
FLUID REMOVAL ASSEMBLY
K840490 · Ackrad Laboratories · Apr 1984
HYPODERMIC SYRINGES & NEEDLES
K834548 · Cordis Corp. · Mar 1984
SYRINGE
K833399 · I M, Inc. · Jan 1984
MULTI PURPOSE SYRINGE
K833435 · I M, Inc. · Dec 1983
DIRECTOR
K832658 · Pharmacia, Inc. · Oct 1983
ANGIOUROGRAPHY KIT
K822159 · Mallinckrodt Critical Care · Nov 1982