Cleared Traditional

K943578 - MONOJECT HIGH VOLUME/CHEMOTHERAPY SHARP...

K943578 is the FDA 510(k) clearance for MONOJECT HIGH VOLUME/CHEMOTHERAPY SHARP... by Sherwood Medical Co.. It is a Class 2 General Hospital device (product code FMI) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K943578 · Sherwood Medical Co. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1994
Decision
32d
Days
Class 2
Risk

K943578 is an FDA 510(k) clearance for the MONOJECT HIGH VOLUME/CHEMOTHERAPY SHARPS CONTAINER. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Sherwood Medical Co. (St. Louis, US). The FDA issued a Cleared decision on August 23, 1994 after a review of 32 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - 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 Sherwood Medical Co. devices

Submission Details

510(k) Number K943578 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1994
Decision Date August 23, 1994
Days to Decision 32 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 129d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FMI Needle, Hypodermic, Single Lumen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
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 - FMI Needle, Hypodermic, Single Lumen

All 235
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K943578.
MONOJECT LUER ADAPTER
K940961 · Sherwood Medical Co. · Sep 1994
MONOJECT HORIZONTAL ENTRY SHARPS CONTAINER
K943485 · Sherwood Medical Co. · Sep 1994
MONOJECT TRAY SIZE SHARPS CONTAINER
K943496 · Sherwood Medical Co. · Aug 1994
BAXTER ONE GALLON SHARPS DISPOSAL CONTAINERS
K943594 · Baxter Healthcare Corp · Aug 1994
BAXTER TWO GALLON SHARPS DISPOSAL CONTAINERS
K943605 · Baxter Healthcare Corp · Aug 1994
BAXTER DISPOSABLE INTRAOSSEOUS INFUSION NEEDLE
K930217 · Baxter Healthcare Corp · Feb 1994