Cleared Traditional

K960982 - MONOJECT BLUNT I.V. ACCESS CANNULA/MONO...

K960982 is the FDA 510(k) clearance for MONOJECT BLUNT I.V. ACCESS CANNULA/MONO... by Sherwood Medical Co.. It is a Class 2 General Hospital device (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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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

Submission Details

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.

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 K960982.
B-D ULTRA-FINE II SHORT 31G X 5/16 PEN NEEDLE
K970737 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1997
LIFESHIELD BLUNT CANNULA
K963351 · Abbott Laboratories · Feb 1997
MANAN PEDIATRIC BONE MARROW ACCESS NEEDLE
K962001 · Manan Medical Products, Inc. · Jan 1997
NON-CORING NEEDLE
K961088 · Arrow Intl., Inc. · Jul 1996
GE STERILE ARTHROGRAM TRAY
K962035 · GE Medical Systems · Jun 1996
B-D ULTRA FINE II, MICRO FINE + SHORT NEEDLE INSULIN SYRINGE
K955235 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1996