Cleared Traditional

K945809 - MONOJECT(R) VERTICAL ENTRY SHARPS CONTAINER (1 QT)

K945809 is an FDA 510(k) clearance for MONOJECT VERTICAL ENTRY SHARPS CONTAINE..., manufactured by Sherwood Medical Co.. The device is a Class 2 General Hospital device with 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

FDA 510(k) Submission Details - K945809

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.

FMI Device Classification - Class 2, Special Controls

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 456
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K945809.
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
SECURE SAFETY INSERT
K945825 · Syncor Intl. Corp. · Apr 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