Cleared Traditional

K934404 - MONOJECT VERTICAL ENTRY SHARPS CONTAINER

K934404 is the FDA 510(k) clearance for MONOJECT VERTICAL ENTRY SHARPS CONTAINER by Sherwood Medical Co.. It is a Class 2 General Hospital device (product code FMI) cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K934404 · Sherwood Medical Co. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
148d
Days
Class 2
Risk

K934404 is an FDA 510(k) clearance for the MONOJECT VERTICAL ENTRY 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 February 4, 1994 after a review of 148 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 K934404 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1993
Decision Date February 04, 1994
Days to Decision 148 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
19d slower than avg
Panel avg: 129d · This submission: 148d
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 K934404.
BAXTER DISPOSABLE INTRAOSSEOUS INFUSION NEEDLE
K930217 · Baxter Healthcare Corp · Feb 1994
CLAVE VIAL ACCESS SPIKE
K934591 · Icu Medical, Inc. · Feb 1994
LIFESHIELD BLOOD COLLECTION DEVICE
K933751 · Sherwood Medical Co. · Feb 1994
AUTO SUTURE SHARPS CONTAINER
K934088 · United States Surgical, A Division of Tyco Healthc · Feb 1994
BECTON DICKINSON LOCKING SAFETY-GARD(TM) IV NEEDLE
K931019 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1993
BARD SAFE SAMPLING DEVICE
K925446 · C.R. Bard, Inc. · Jul 1993