Cleared Traditional

K960982 - MONOJECT BLUNT I.V. ACCESS CANNULA/MONOJECT HYPODERMIC SYRINGE WITH BLUNT I.V. ACCESS CANNULA

K960982 is an FDA 510(k) clearance for MONOJECT BLUNT I.V. ACCESS CANNULA/MONO..., 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 287-day FDA review.

K960982 · Sherwood Medical Co. · General Hospital
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Optimized for regulatory review, auditing and printing
Dec 1996
Decision
287d
Days
Class 2
Risk

K960982 is an FDA 510(k) clearance for the MONOJECT BLUNT I.V. ACCESS CANNULA/MONOJECT HYPODERMIC SYRINGE WITH BLUNT I.V.... 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 December 23, 1996 after a review of 287 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

FDA 510(k) Submission Details - K960982

510(k) Number K960982 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1996
Decision Date December 23, 1996
Days to Decision 287 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
158d slower than avg
Panel avg: 129d · This submission: 287d
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 455
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K960982.
SHARPS CONTAINER MODEL# SC001
K963830 · Image Medical, Inc. · Feb 1997
MANAN PEDIATRIC BONE MARROW ACCESS NEEDLE
K962001 · Manan Medical Products, Inc. · Jan 1997
SERAGARD VASCULAR ACCESS DEVICE
K963595 · Cutting Edge Technologies, Inc. · Jan 1997
I.V. START KIT
K950686 · James J. Schramm · Oct 1996
SAFETY CRADLE
K962149 · Specialized Health Products, Inc. · Oct 1996
BIO-PLEXUS NEEDLE DISPOSAL CONTAINER
K960933 · Bio-Plexus, Inc. · Aug 1996