Cleared Traditional

K884589 - FRANTZ MEDICAL SHARPS COLLECTOR

K884589 is the FDA 510(k) clearance for FRANTZ MEDICAL SHARPS COLLECTOR by Franklin Medical USA, Inc.. It is a Class 2 General Hospital device (product code FMF) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K884589 · Franklin Medical USA, Inc. · General Hospital
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Dec 1988
Decision
36d
Days
Class 2
Risk

K884589 is an FDA 510(k) clearance for the FRANTZ MEDICAL SHARPS COLLECTOR. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Franklin Medical USA, Inc. (Mentor, US). The FDA issued a Cleared decision on December 9, 1988 after a review of 36 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 Franklin Medical USA, Inc. devices

Submission Details

510(k) Number K884589 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1988
Decision Date December 09, 1988
Days to Decision 36 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
93d faster than avg
Panel avg: 129d · This submission: 36d
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 294
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K884589.
30-CS01, 30-CS02, 30-CS03 CONTROL SYRINGES
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DISPENSING PIN/CHEMOTHERAPY DISPENSING PIN
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SINGLE-FIL(TM) SYRINGE
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MANAN HUBER STYLE INFUSION NEEDLE
K883744 · Manan Medical Products, Inc. · Sep 1988
BD MICROFINE IV PEN INJECTOR
K881775 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1988