Cleared Traditional

K843415 - TOP HYPODERMIC SYRINGE LUER LOCK

K843415 is the FDA 510(k) clearance for TOP HYPODERMIC SYRINGE LUER LOCK by Top Surgical Manufacturers Co.. It is a Class 2 General Hospital device (product code FMF) cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K843415 · Top Surgical Manufacturers Co. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1984
Decision
98d
Days
Class 2
Risk

K843415 is an FDA 510(k) clearance for the TOP HYPODERMIC SYRINGE LUER LOCK. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Top Surgical Manufacturers Co. (Littleton, US). The FDA issued a Cleared decision on December 7, 1984 after a review of 98 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 Top Surgical Manufacturers Co. devices

Submission Details

510(k) Number K843415 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1984
Decision Date December 07, 1984
Days to Decision 98 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
31d faster than avg
Panel avg: 129d · This submission: 98d
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 254
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K843415.
MONOJECT STERILE 12CC SYRINGES, W/WO NEEDLES
K851089 · Sherwood Medical Co. · Apr 1985
MONOJECT STERILE 1/2 CC & 1CC SYRINGES W & W/O NEE
K851090 · Sherwood Medical Co. · Apr 1985
SYRINGE W/NEEDLE COMBIN & SYRINGE ONLY
K844106 · Abco Dealers, Inc. · Jan 1985
HYPODERMIC SYRINGES & NEEDLES
K834548 · Cordis Corp. · Mar 1984
DIRECTOR
K832658 · Pharmacia, Inc. · Oct 1983
ANGIOUROGRAPHY KIT
K822159 · Mallinckrodt Critical Care · Nov 1982