Cleared Traditional

K843415 - TOP HYPODERMIC SYRINGE LUER LOCK

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

K843415 · Top Surgical Manufacturers Co. · General Hospital
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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

FDA 510(k) Submission Details - K843415

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.

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 524
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K843415.
MONOJECT STERILE 1/2 CC & 1CC SYRINGES W & W/O NEE
K851090 · Sherwood Medical Co. · Apr 1985
BLOOD GAS SAMPLER KIT
K850958 · Churchill Corp. · Apr 1985
SYRINGE W/NEEDLE COMBIN & SYRINGE ONLY
K844106 · Abco Dealers, Inc. · Jan 1985
PHARMA-PLAST SYRINGE
K843471 · Zimmar Consulting , Ltd. · Oct 1984
PHARMA-PLAST SYRINGE WITH NEEDLE
K843472 · Zimmar Consulting , Ltd. · Oct 1984
PHARMA-PLAST INSULIN SYRINGE
K843473 · Zimmar Consulting , Ltd. · Oct 1984