Cleared Traditional

K951515 - MONOJECT VERTICAL ENTRY CHEMOTHERAPY SH...

K951515 is the FDA 510(k) clearance for MONOJECT VERTICAL ENTRY CHEMOTHERAPY SH... by Sherwood Medical Co.. It is a Class 2 General Hospital device (product code FMI) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K951515 · Sherwood Medical Co. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
50d
Days
Class 2
Risk

K951515 is an FDA 510(k) clearance for the MONOJECT VERTICAL ENTRY 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 May 23, 1995 after a review of 50 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 K951515 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1995
Decision Date May 23, 1995
Days to Decision 50 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
79d faster than avg
Panel avg: 129d · This submission: 50d
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 K951515.
SAFETYGLIDE NEEDLE
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BECTON DICKINSON BLUNT STEEL CANNULA
K944931 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1995
DEVONS POINT LOK NEEDLE PROTECTION DEVICE
K946289 · Devon Industries, Inc. · Jul 1995
B-D ULTRA-FINE II PEN NEEDLE
K950466 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1995
MONOJECT(R) VERTICAL ENTRY SHARPS CONTAINER (1 QT)
K945809 · Sherwood Medical Co. · Mar 1995
PISTON SYRINGES
K944757 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1995