Cleared Traditional

K940961 - MONOJECT LUER ADAPTER

K940961 is the FDA 510(k) clearance for MONOJECT LUER ADAPTER by Sherwood Medical Co.. It is a Class 2 General Hospital device (product code FMI) cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K940961 · Sherwood Medical Co. · General Hospital
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Sep 1994
Decision
196d
Days
Class 2
Risk

K940961 is an FDA 510(k) clearance for the MONOJECT LUER ADAPTER. 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 September 14, 1994 after a review of 196 days - an extended review 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: 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 K940961 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1994
Decision Date September 14, 1994
Days to Decision 196 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
67d slower than avg
Panel avg: 129d · This submission: 196d
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 K940961.
PHLEBOTOMY UNIT SHARPS A GATOR
K944114 · Devon Industries, Inc. · Dec 1994
CHEMOTHERAPY SHARPS DISPOSAL CONTAINERS
K943722 · Baxter Healthcare Corp · Nov 1994
B-D GUARDIAN NESTABLE SHARPS COLLECTORS
K943575 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1994
MONOJECT HORIZONTAL ENTRY SHARPS CONTAINER
K943485 · Sherwood Medical Co. · Sep 1994
MONOJECT TRAY SIZE SHARPS CONTAINER
K943496 · Sherwood Medical Co. · Aug 1994
MONOJECT HIGH VOLUME/CHEMOTHERAPY SHARPS CONTAINER
K943578 · Sherwood Medical Co. · Aug 1994