Cleared Traditional

K945809 - MONOJECT VERTICAL ENTRY SHARPS CONTAINE...

K945809 is the FDA 510(k) clearance for MONOJECT VERTICAL ENTRY SHARPS CONTAINE... by Sherwood Medical Co.. It is a Class 2 General Hospital device (product code FMI) cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K945809 · Sherwood Medical Co. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
107d
Days
Class 2
Risk

K945809 is an FDA 510(k) clearance for the MONOJECT(R) VERTICAL ENTRY SHARPS CONTAINER (1 QT). Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Sherwood Medical Co. (St. Joseph, US). The FDA issued a Cleared decision on March 15, 1995 after a review of 107 days - within the typical 510(k) review window.

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: 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 Sherwood Medical Co. devices

Submission Details

510(k) Number K945809 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1994
Decision Date March 15, 1995
Days to Decision 107 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
22d faster than avg
Panel avg: 129d · This submission: 107d
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 K945809.
DEVONS POINT LOK NEEDLE PROTECTION DEVICE
K946289 · Devon Industries, Inc. · Jul 1995
MONOJECT VERTICAL ENTRY CHEMOTHERAPY SHARPS CONTAINER
K951515 · Sherwood Medical Co. · May 1995
B-D ULTRA-FINE II PEN NEEDLE
K950466 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1995
PISTON SYRINGES
K944757 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1995
POINT OF USE SHARPS A GATOR
K943892 · Devon Industries, Inc. · Dec 1994
PHLEBOTOMY UNIT SHARPS A GATOR
K944114 · Devon Industries, Inc. · Dec 1994